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WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6663582.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case CoaguChek ProII Operators Manual CoaguChek ProII Operators Manual Publication version 5.0 Software version 04.07 08251398001 (05) 2023-02 EN-CAN Publication information 3 Revision date Changes Manual version 1.0 2.0 2017-09 2018-09 3.0 2020-10 4.0 2022-08 5.0 2023-02 License information New document, based on international CoaguChek ProII manual 07154879001(04)EN2017-04. Software update, valid for SW04.03.xx; new features:
lockout configuration extension; QC interval reset;
miscellaneous editorial revisions.Based on international CoaguChek ProII manual 07154879001(05)EN2018-09. Software update, valid for SW04.04.xx. All changes included from addendum, Version 1, 2019-09, 09073434001(01)2019-09EN. Software update, valid for SW04.05.xx. Implementation of IVDR related requirements (IVDR: in vitro diagnostics regulation). Software update, valid for SW04.07.xx; new features: technical integration with cobas infinity edge, meter credentials, configuration barcodes; miscellaneous editorial revisions. New WLAN chip for communication using the 5 GHz band;
editorial revisions. The contents of this document, including all graphics, are the property of Roche Diagnostics. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Roche Diagnostics. Roche Diagnostics has made every reasonable effort to ensure that all the information contained in this manual is correct at the time of printing. However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of ongoing product development. CoaguChek ProII Operators Manual 4 User documentation Electronic user documentation can be downloaded using the eLabDoc e-service on Dialog:
Copyright Trademarks www.dialog.roche.com For more information, contact your local affiliate or Roche Service representative. 2015-2023 Roche Diagnostics GmbH. All rights reserved. ACCUCHEK, COAGUCHEK and SAFETPRO are trademarks of Roche. All other trademarks are the property of their respective owners. Approvals The CoaguChek ProII system meets the requirements laid down in:
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonization of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC. CoaguChek ProII Operators Manual 5 The WiFi CERTIFIED Logo is a certification mark of the WiFi Alliance. In vitro diagnostic medical device Complies with the provisions of the applicable EU regulations. The system fulfils the Canadian and U.S. safety requirements (UL LISTED, in accordance with UL 61010A1:02 and CAN/CSAC22.2 No.61010104). Eurasian Conformity. Demonstrates that the product meets the Eurasian Economic Union (EAEU)s regulations and standards for customs clearance and trading. On meters with WLAN capability:
This device complies with Part 15 of the FCC Rules and with RSS247 of Industry Canada. For other WLAN certifications, see label on bottom of battery compartment and addendum for information on WLAN registration. CoaguChek ProII Operators Manual IVD 6 Symbols and abbreviations On the packaging and on the identification plate of the instrument you may encounter the following symbols, shown here with their meaning:
Caution, consult accompanying documents. Refer to safetyrelated notes in the instructions for use accompanying this product. CoaguChek Pro II meter Operators Manual Power supply Temperature limitation (Store at) Admissible humidity (Store at) Use by Manufacturer Date of manufacture Batch code/ Lot number Catalog number Global Trade Item Number Unique device identifier CoaguChek ProII Operators Manual LOT 7 Serial Number Device for near-patient testing Device not for self-testing Consult instructions for use Power supply connection Contents of the pack CoaguChek ProII Operators Manual SN12V1.25ACONTENT 8 Page intentionally left blank. CoaguChek ProII Operators Manual 9 Table of contents 1 2 3 4 5 Publication information........................................................................... Symbols and abbreviations...................................................................... 3 6 What is new in publication version 5.0?....................................................... 11 Introduction 1.1 Before you start .............................................................................. 1.2 Important safety instructions and additional information ........................... 1.3 Overview of the meter elements .......................................................... 1.4 Buttons and icons overview ................................................................ 1.5 Power supply .................................................................................. Putting the Meter into Operation 2.1 Installing or replacing the battery pack ................................................. 2.2 Powering the meter on and off ............................................................ 13 13 18 32 34 39 41 42 47 49 Meter Setup 49 3.1 Display of screen elements................................................................. 51 3.2 Settings summary ............................................................................ 3.3 Screen setup .................................................................................. 58 68 3.4 Options setup ................................................................................. 84 3.5 ID setup ......................................................................................... 3.6 QC Settings setup ............................................................................ 93 3.7 Diagnostics .................................................................................... 108 Testing a Blood Sample 111 4.1 Important notes............................................................................... 111 4.2 Preparing to test.............................................................................. 115 4.3 Performing a test ............................................................................. 120 133 Control and Proficiency Testing 5.1 Control testing ................................................................................ 133 5.2 Preparing to perform a liquid quality control test ..................................... 134 5.3 Performing a liquid quality control test.................................................. 137 5.4 Proficiency testing ........................................................................... 144 5.5 Preparing to perform a proficiency test ................................................. 145 5.6 Performing a proficiency test.............................................................. 146 CoaguChek ProII Operators Manual 10 6 7 8 9 Review Results (Memory) 151 6.1 Viewing test results .......................................................................... 152 157 Extended Functionalities 7.1 Data handling.................................................................................. 157 Maintenance and Care 165 8.1 Conditions for storage and shipping ..................................................... 165 8.2 Cleaning and disinfecting the meter ..................................................... 167 8.3 Cleaning/disinfecting the exterior (meter housing) ................................... 170 8.4 Cleaning/disinfecting the test strip guide............................................... 173 8.5 Maintenance cleaning of the interior test strip guide in case of residue buildup .............................................................................................. 177 8.6 Cleaning the scanner window.............................................................. 179 8.7 Cleaning after a notification appears .................................................... 180 183 Troubleshooting 9.1 Status / Error messages..................................................................... 183 9.2 Shut down / restart / reset meter ......................................................... 189 10 General Product Specifications 193 10.1 Technical data............................................................................... 193 10.2 Further information......................................................................... 195 11 Warranty 199 12 Appendix A 201 A.1 Operator and patient ID barcode masks ................................................ 201 A.2 Example of barcode symbologies......................................................... 202 A.3 Supported characters in 2D barcodes................................................... 206 13 Appendix B 207 B.1 Supplement for Observed Test Sequence .............................................. 207 Using the OTS function........................................................................... 208 14 Appendix C 211 C.1 Option: Wireless network (WLAN)......................................................... 211 Index 217 CoaguChek ProII Operators Manual 11 What is new in publication version 5.0?
This section provides an overview of all major changes from Operators Manual version 4.0 to version 5.0. Deletions or minor corrections are not listed. Other revisions Updated information on radiofrequency radiation exposure. u Radiofrequency radiation exposure information
(27) i
0 5 n o s r e v n o i t a c i l b u p n i w e n s i t a h W CoaguChek ProII Operators Manual 12 Page intentionally left blank. CoaguChek ProII Operators Manual 13 1 Introduction 1.1 Before you start Intended use The CoaguChek ProII is an in vitro diagnostic instrument intended for the determination of PT and aPTT in whole blood using the CoaguChekPT Test and CoaguChekaPTT Test. The CoaguChek ProII is intended for near-patient testing by healthcare professionals. Not for self-testing. Important information regarding use Released and launched parameters are countryspecific. Only parameters available on the market in the respective country can be activated. Read this operator's manual, as well as the package inserts for all relevant consumables, before using the system for the first time. You must configure the CoaguChek ProII meter according to your needs before initial use. Refer to Chapter3, Meter Setup. Be sure to read the Important safety instructions and additional information section in this chapter before operating the system. Before you use the meter for the first time (after you have first inserted the battery pack), you must set the date and time correctly to allow you to perform measurements properly. Each time you replace the battery pack you need to check (and, if necessary adjust) the date and time. QC Lockout is disabled by default. For routine confirmation of system reliability it is recommended to enable this feature. u To set the time (65) 1 n o i t c u d o r t n I 1 CoaguChek ProII Operators Manual If you need help General note What can the system do for you?
14 1 n o i t c u d o r t n I 1 u To set the date (64) u To set the date and time format (66) u QC (quality control) Lockout (98) Information about using the system, the screen menus, and performing a test can be found in this manual. When error messages appear on the screen, refer to Chapter 9, Troubleshooting starting with 9.1 Status /
Error messages (183). For all questions about the CoaguChek ProII system that are not answered in this manual, contact your Roche Diagnostics representative. In order to expedite troubleshooting, please have ready your CoaguChek ProII meter, its serial number, this manual, and all related consumables when you call. The data and information provided in this manual are current as of issue. Any substantial changes will be incorporated in the next edition. If there is any conflict of information, the package insert included with the CoaguChek test strips shall prevail. The CoaguChek ProII system makes coagulation testing easy. You only need to insert the code chip, power the meter on, insert the test strip for the CoaguChekPT Test or the aPTT Test, and apply a small blood sample. The blood mixes with the reagents on the test strip, and the meter determines when the blood clots. Depending on which test parameter is selected, the meter displays the results after approximately one minute (PT) or after several minutes (aPTT). After the measurement, the meter automatically stores the test result, together with date/time and patient ID (and operator ID, if that option is enabled) to memory. CoaguChek ProII Operators Manual The CoaguChek ProII meter displays test results in units equivalent to laboratory plasma measurements. Results may be displayed in the following ways:
Parameter: aPTT seconds Parameter: PT International Normalized Ratio (INR) combination of INR/seconds, or combination of INR/%Quick INR is a standardized measurement of the rate at which blood clots. A low INR can indicate an increased risk of blood clots, while an elevated INR can indicate increased risk of bleeding. The meter guides you through the test, step by step, using icons and instructions on the display. Each box of test strips has its own code chip that you insert into the meter. This code chip contains lotspecific information about its test strips, such as the expiration date and calibration data. Optional liquid controls for the system are also available. The CoaguChek ProII meter has the ability to connect to a data management system (DMS) through the Handheld Base Unit from Roche Diagnostics (available separately) or via wireless communication (WLAN). The CoaguChek ProII meter supports data exchange via the POCT1A standard. Data management systems may have the ability to expand the security features of the meter, such as enabling operator lockouts. Data management systems may also enable data transfer to a hospital information system (HIS) or to a laboratory information system (LIS). Refer to the manuals of the Handheld Base Unit and of your DMS for technical details. 15 1 n o i t c u d o r t n I 1 CoaguChek ProII Operators Manual 16 Test principle Contents of the pack The CoaguChek Tests contain desiccated reagents. These consist of activators, a peptide substrate, and nonreactive components. When a sample is applied to a test strip, the reagent dissolves and the activators start the coagulation process, leading to the formation of the enzyme thrombin. Simultaneously the meter starts to measure the time. Thrombin cleaves the peptide substrate, generating an electrochemical signal. Depending on the time elapsed when this signal first appears, it is converted via an algorithm into customary coagulation units (depending on the test, into INR,
%Quick, or seconds) and the result is displayed. The CoaguChek ProII pack contains the following items:
CoaguChek ProII meter Additional test strip guide cover (spare part) Battery compartment cover Universal Battery Pack Power supply Starshaped screwdriver Operators Manual (printed version, not shown here) Check for completeness and transport damage immediately after unpacking. 1 n o i t c u d o r t n I 1 CoaguChek ProII Operators Manual 17 1 n o i t c u d o r t n I 1 CoaguChek ProII Operators Manual 18 1 n o i t c u d o r t n I 1 1.2 Important safety instructions and additional information This section explains how safetyrelated messages and information related to the proper handling of the system are presented in the CoaguChek ProII Operators Manual. Read these passages carefully. Safety alert r The safety alert symbol alone (without a signal word) promotes awareness to hazards which are generic or directs the reader to related safety information. These symbols and signal words are used for specific hazards:
WARNING!
Warning r indicates a hazardous situation that, if not avoided, could result in death or serious injury. CAUTION!
Caution r indicates a hazardous situation that, if not avoided, could result in minor or moderate injury. NOTICE!
Notice... ..indicates a hazardous situation that, if not avoided, may result in damage to the system. CoaguChek ProII Operators Manual Important information that is not safety relevant is presented against a colored background (without a symbol). Here you will find additional information on correct use of the meter or useful tips. Illustrations in this manual show two different kinds of hands:
Hand without glove Hand with glove A dashed arrow between screen illustrations indicates that some screens have been skipped in these illustrations. Safety information Operator qualification r Only trained healthcare professionals may operate the CoaguChek ProII system. Operators must have received comprehensive instruction in the operation, quality control, and care of the CoaguChek ProII system. Incident reporting r Inform your Roche representative and your local competent authority about any serious incidents which may occur when using this product. CoaguChek ProII Operators Manual 19 1 n o i t c u d o r t n I 1 20 1 n o i t c u d o r t n I 1 WARNING!
Protection against infection and bloodborne pathogens Healthcare professionals using the CoaguChek ProII system to perform tests must be aware that any object coming into contact with human blood is a potential source of infection. Operators need to adhere to Standard Precautions when handling or using the CoaguChek ProII system. All parts of this system should be considered potentially infectious and are capable of transmitting bloodborne pathogens between patients and between patients and healthcare professionals. r Use gloves. Wear a new pair of clean gloves for testing each patient and control test. r Wash hands thoroughly with soap and water before putting on a new pair of gloves and performing the next patient test. r Use an autodisabling singleuse lancing device for each patient. r Dispose of used lancets in a sturdy sharps container with lid. r Dispose of used test strips from patient and proficiency tests according to your institutions infection control policy. r Follow all health and safety regulations in force locally. CoaguChek ProII Operators Manual CAUTION!
Allergy or injury caused by reagents and other working solutions Direct contact with reagents, detergents, cleaning/
disinfection solutions, or other working solutions may cause skin irritation or inflammation. r Always use protective gloves. r Observe the cautions given in the package inserts of the reagents and cleaning/disinfection solutions. r If a reagent, control, linearity, or cleaning/
disinfection solution comes into contact with your skin, wash it off immediately with water. r Follow all health and safety regulations in force locally. WARNING!
Avoidance of electrical shock, fire, and explosions r Only use Roche Diagnostics original accessories
(cables, power supply units, battery packs, and spare parts). Thirdparty cables, power supply units, and battery packs can cause the battery pack to explode or the meter to become damaged. r Do not use loose power sockets or damaged power supply units, cables, plugs, or battery packs. r Do not short circuit the power supply unit, the Handheld Base Unit contacts, or the battery pack. r Do not drop the CoaguChek ProII meter, the power supply unit, or the battery pack and protect these against shaking and vibrations. 21 1 n o i t c u d o r t n I 1 CoaguChek ProII Operators Manual 22 1 n o i t c u d o r t n I 1 Disposal of the system WARNING!
Infection by a potentially biohazardous instrument The CoaguChek ProII system or its components must be treated as potentially biohazardous waste. Decontamination (i.e., a combination of processes including cleaning, disinfection and/or sterilization) is required before reuse, recycling, or disposal. Dispose of the system or its components according to the appropriate local regulations. Always remove the battery pack before thermal disinfection. General care NOTICE!
Battery pack Clean the meter only with the solutions recommended. Using other solutions may result in incorrect operation and possible system failure. Do not let cleaning solution enter the instrument. Make sure that the meter is thoroughly dried after cleaning or disinfecting. The meter contains a rechargeable battery pack that begins charging as soon as the power adapter is connected or the meter is placed on an active Handheld Base Unit (i.e., one connected to a power supply). NOTICE!
r Use only the specially designed battery pack provided by Roche Diagnostics. Using any other type of battery may damage the system. CoaguChek ProII Operators Manual 23 WARNING!
Possible hazards posed by the battery pack Damaged or swollen battery packs can overheat, catch fire, or leak. Immediately cease use of CoaguChek ProII meters with damaged or swollen battery packs and under no circumstances recharge them (do not place in the Handheld Base Unit). Overheating can cause the battery pack to catch fire or explode. Battery fluid or materials leaking from damaged battery packs can irritate your skin or cause burns due to high temperatures. r Never throw the battery pack or the meter onto a fire. Do not dismantle, compress, or pierce the battery pack as this could cause an internal short circuit that leads to overheating. r Do not place either the battery pack or the CoaguChek ProII meter on or in heating appliances, such as a microwave, conventional oven, or radiator. r Avoid prolonged exposure to direct sunlight, e.g., when the meter is docked in the Handheld Base Unit. Keep this in mind when positioning the Handheld Base Unit. r Avoid contact with leaking battery fluid. In the event of accidental contact with the skin, rinse with water. If you get battery fluid in your eye(s), you should also seek medical attention. r Handle and dispose of battery packs with care. Extreme temperatures reduce the charging capacity and usage period of the meter and the battery pack. Observe the following general safety instructions for handling the battery pack:
1 n o i t c u d o r t n I 1 CoaguChek ProII Operators Manual 24 1 n o i t c u d o r t n I 1 Disposal of used battery packs Do not dispose of the battery pack with normal domestic waste. Dispose of used battery packs in accordance with applicable local regulations and directives and your facilitys guidelines on the disposal of electronic waste equipment. Save or download data from the meter prior to replacing the battery pack to prevent loss of data (see Chapter7 starting with Data handling). When storing or disposing of the battery pack, use the manufacturer's original packaging. Always power the meter off before removing the battery pack. When the Battery Low warning is displayed, the meter must be returned as soon as possible to the Handheld Base Unit or connected to the power adapter for recharging. When the battery capacity is too low for further tests, the meter must be returned immediately to the Handheld Base Unit or connected to the power adapter for recharging. If the meter displays a large red battery icon instead of powering up when you press the On/Off button, this indicates that the battery is empty. Immediately return the meter to the Handheld Base Unit or connect to the power adapter for recharging. u 7.1 Data handling (157) Electromagnetic interference The meter fulfills the IEC6132626 requirements for emitted interference and interference immunity. CoaguChek ProII Operators Manual Touchscreen Local Area Network:
protection from unauthorized access 25 r Do not use the meter near strong electromagnetic fields, which could interfere with the proper operation of the meter. r As security improvement, the instrument detects interferences caused by electrostatic discharges during measurements. In this case the affected measurement is stopped. NOTICE!
r Use only your finger (even when wearing gloves) or special pens designed for use with touchscreens to touch the screen elements. Using pointed or sharpedged objects can damage the touchscreen. r Avoid prolonged exposure to direct sunlight. Direct sunlight may reduce the life expectancy and functionality of the display. If this meter is connected to a local area network, this network must be protected against unauthorized access. In particular, it must not be linked directly to any other network or the Internet. Customers are responsible for the security of their local area network, especially in protecting it against malicious software and attacks. This protection might include measures, such as a firewall, to separate the device from uncontrolled networks as well as measures that ensure that the connected network is free of malicious code. If user data and/or passwords are altered by means of a compromised DMS the meter might become unusable. If you use a customized data management system solution, ensure that sensitive data transmitted via the POCT1A interface is protected by appropriate security measures. 1 n o i t c u d o r t n I 1 CoaguChek ProII Operators Manual Wired network connection 26 1 n o i t c u d o r t n I 1 Ensure that the instrument is protected against unauthorized physical access and theft. Do not use shared user or operator accounts on meter, DMS and network. Whether working in a wired or wireless environment, use a strong password for user or operator accounts on the meter, DMS, and network. Observe your own facility guidelines on password management where available, or apply the rules for strong passwords, see Characteristics of strong passwords below. If the Handheld Base Unit from Roche Diagnostics is used to connect this meter to a local area network, the Handheld Base Unit must be protected against unauthorized access by means of a strong password management. Observe your own facility guidelines on password management where available, or apply the following rules:
Characteristics of strong passwords Passwords should not contain the users account name or parts of the users full name that exceed two consecutive characters. Passwords should be at least eight characters in length. Passwords should contain characters from the following three categories:
English uppercase alphabetic characters (A through Z) English lowercase alphabetic characters (a through z) Numeric characters (0 through 9) Characteristics of weak passwords CoaguChek ProII Operators Manual Wireless connectivity Radiofrequency radiation exposure information 27 uhxwze11 contains no upper case letter. UHXW13SF contains no lower case letter. uxxxxx7F contains the same character more than four times. x12useridF contains a substring of the user ID longer than four characters. If the meter is equipped with WLAN functionality:
Wireless connectivity allows the meter to send data
(test results, patient IDs, operator IDs, etc.) to the data management system without the need to return the meter to the Handheld Base Unit. This feature must be configured by the system administrator. Observe the guidelines of your facility for using wireless local area network connections. For a description of the CoaguChek ProII meters ability to connect to Wireless Local Area Networks (WLAN, WiFi), see appendix C.1. u C.1 Option: Wireless network (WLAN) (211) Glossary:
FCC stands for Federal Communications Commission (USA). RF stands for radio frequency RSS stands for Radio Standards Specification (Canada). WLAN stands for Wireless Local Area Network The Industrial, Scientific and Medical (ISM) radio frequencies may contain emissions from microwave ovens, heaters, and other noncommunication devices. While these types of devices usually pose no threat of interference as they are lowpowered devices, the possibility exists that some industrial high power systems may wipe out any attempted communication use of a WLAN. Therefore, perform a site survey and 1 n o i t c u d o r t n I 1 CoaguChek ProII Operators Manual 28 1 n o i t c u d o r t n I 1 interference analysis with a spectrum analyzer to view the entire spectrum, looking for signals that might not only be within the frequency range of the intended WLAN but also could be near or at the same frequency and cause interference. Roche Diagnostics supports industry wireless standards and recommends using products that have WiFi certification. This certification tests products to the 802.11 industry standards for basic connectivity, security, authentication, Quality of Service (QoS), interoperability and reliability. The WiFi CERTIFIED logo is an assurance that the WiFi Alliance has tested a product in numerous configurations and with a diverse sampling of other devices to ensure compatibility with other WiFi CERTIFIED equipment that operates in the same frequency band. The WiFi Alliance network of independent test labs conducts interoperability testing programs to ensure that wireless devices work together and support secure connections. The CoaguChek ProII system complies with FCC radiation exposure limits set forth for an uncontrolled environment. Radiofrequency radiation exposure Information: This device has been tested and meets the FCC/ISED RF exposure guidelines. Nevertheless, the device should be used in such a manner that the potential for human contact during normal operation is minimized. Note: The UNII-1 band (5150-5250 MHz) is only allowed for indoor use in Canada. This transmitter must not be colocated or operated in conjunction with any other antenna or transmitter. CoaguChek ProII Operators Manual Changes or modifications made to this equipment not expressly approved by Roche Diagnostics may void the FCC authorization to operate this equipment. This device complies with Part15 of the FCC Rules and with RSS247 of Industry Canada. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause undesired operation The CoaguChek ProII system complies with the emission and immunity requirements described in EN6132626. It has been designed and tested to CISPR11 ClassB. This equipment has been tested and found to comply with the limits for a ClassB digital device, pursuant to Part15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by powering the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. 29 1 n o i t c u d o r t n I 1 CoaguChek ProII Operators Manual 30 1 n o i t c u d o r t n I 1 Operating conditions Quality control Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. This Class B digital apparatus complies with Canadian ICES003. To ensure that the meter functions properly, please observe the following guidelines:
Only use the meter at a room temperature between 12C and 32C (54F and 90F). For information on operating temperatures of test strips refer to the test strip package inserts. Test strip operating temperatures may differ from test parameter to test parameter. Only use the meter at a relative humidity between 10% and 85% (no condensation). When operating the meter using the power adapter, use only a voltage of 100V to 240V (10%) , 50/60Hz. When testing, place the meter on a level, vibrationfree surface, or hold it so it is roughly horizontal. The meter has a number of builtin qualitycontrol functions:
A check of the electronic components and functions every time the meter is powered on. A check of the test strip temperature while a test is in progress. A check of the expiration date and lot information on the test strip based on the code chip data. An onboard quality control within every single test strip. CoaguChek ProII Operators Manual Roche Diagnostics offers liquid quality controls for the CoaguChek ProII system. These controls are designed to assist you in meeting regulatory compliance requirements at your facility. 31 1 n o i t c u d o r t n I 1 CoaguChek ProII Operators Manual 32 1.3 Overview of the meter elements 1 n o i t c u d o r t n I 1 CoaguChek ProII Operators Manual EFGHIJABCDE A Touchscreen Shows test results, information, icons, and results recalled from memory. To select an option, simply touch the button lightly. F Battery compartment cover Remove to insert the battery pack B On/Off button G Charging contacts Press this button to power the meter on or off. Used for power supply and/or charging the battery pack when the meter is docked in the (optional) Handheld Base Unit. C Test strip guide cover H Code chip slot (shown with code chip) Remove this cover to clean the test strip guide (if it has become soiled, e.g., with blood). D Test strip guide Insert the test strip here. Insert the code chip here. I Connection socket for power adapter Plug in the power adapter here. E Barcode scanner J Infrared interface The integrated barcode scanner can scan operator, patient, and QC sample IDs into the meter.
(Covered by the semitransparent panel) Supports data communication. CoaguChek ProII Operators Manual 33 1 n o i t c u d o r t n I 1 34 1.4 Buttons and icons overview The buttons and icons that appear during normal operation are shown here, along with their respective meanings. Button/Icon Meaning Go to Main Menu OK; save setting Cancel; discard setting Return (to previous menu) Decrease/increase the value displayed. Scroll through lists that are too long to be displayed all at once. Inactive button: Value cannot be further decreased/increased or: End of list in this direction is reached List of tests of a specific patient Print after test result or from memory Display test result as QR code Add a comment Operator must wait until the meter has completed an action CoaguChek ProII Operators Manual 1 n o i t c u d o r t n I 1 Button/Icon Meaning Insert test strip Remove test strip Apply sample (the time left to apply sample is counted down in the display) Apply liquid control (QC) sample (the time left to apply sample is counted down in the display) Insert the test strip code chip Insert the QC code chip Automatic quality control completed successfully Results are displayed as a Quick percentage value Results are displayed in seconds Results are displayed in INR units Result in the chosen unit of measure is above the measuring range. Result in the chosen unit of measure is below the measuring range. CoaguChek ProII Operators Manual 35 1 n o i t c u d o r t n I 1 QCQC%QSECINR 36 1 n o i t c u d o r t n I 1 Button/Icon Meaning Quality control: Result is above the specified range Quality control: Result is below the specified range Battery status:
Battery full: When the battery pack is fully charged, all segments are lit. Battery good: One missing segment indicates a partially charged battery pack. Battery half: Two missing segments indicate a partially charged battery pack. Battery low: When there is only one segment remaining the icon is displayed in red. Battery empty: When there is no segment remaining, you may not be able to finish performing a test. Recharge as soon as possible. When the power supply icon is displayed, the meter is connected to the power supply adapter or the HBU. Charging is possible when the meter enters standby mode. Time between midnight and noon (in 12hour time format) Time between noon and midnight (in 12hour time format) Room or meter temperature is outside the acceptable range The test strip guide cover is open Reports a status message (see Chapter 9, Troubleshooting) Reports an error message or a warning (see Chapter 9, Troubleshooting) CoaguChek ProII Operators Manual ampm Button/Icon Meaning Lockout, one or more parameters are locked Reset; resets setup The following icons may appear when using the meter in conjunction with a data management system (DMS). Button/Icon Meaning If displayed in the status bar: communication is taking place via the infrared interface. Last synchronization passed. Last synchronization failed. If displayed in the status bar: communication is taking place via WLAN. Last synchronization passed. Last synchronization failed. If displayed in the status bar: communication security status. The last communication with the data management system was neither TLS encrypted nor TLS authenticated. The last communication with the data management system was TLS encrypted, but not TLS authenticated. The last communication with the data management system was both TLS encrypted and TLS authenticated. An OTS request is pending Cleaning/Disinfection is necessary Patient test result is out of normal patient test range CoaguChek ProII Operators Manual 37 1 n o i t c u d o r t n I 1 QC!
38 Button/Icon Meaning Approved; indicates server or root CA certificate status as approved. For manual server certificate approval. Not Approved; indicates server certificate status as not approved. Expired; indicates server or root CA certificate is expired. Delete; for certificate deletion. Download; for downloading credentials. The communication security icon security status of current or last communication with the data management system. The icon is shown permanently after the initial communication of a brand new meter has taken place. indicates the Error messages and the description of the icons linked to them are provided in the Troubleshooting chapter. 1 n o i t c u d o r t n I 1 CoaguChek ProII Operators Manual 1.5 Power supply 39 The CoaguChek ProII meter is exclusively operated with the rechargeable battery pack. Always insert the battery pack, even when using the power adapter. This ensures smooth operation and prevents a loss of the date and time settings if the power goes out. The meter cannot be operated without a battery pack. Unused battery packs lose their charge over time and have to be recharged before they can be used. After installing a new battery pack, the meter should be charged at least 4hours before testing, preferably overnight. To save power, the CoaguChek ProII meter has an automatic poweroff function (autooff). The default setting is 5 minutes of inactivity (e.g., no screen touches). It is possible to customize the auto-off function via your Setup selection (see Auto Off). When the meter powers itself off, all results are automatically saved to memory. u To enable the auto off option (71) During battery operation, the meter always displays the battery power level. When replacing the battery pack, insert the new battery pack within 10minutes of removing the old one. Otherwise you may need to reenter date and time. 1 n o i t c u d o r t n I 1 Battery power level CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetup 40 1 n o i t c u d o r t n I 1 The meter retains results in memory even when no battery pack is inserted. All settings other than date and time are retained as well. r Dispose of used battery packs in an environmentally responsible manner in accordance with applicable local regulations and directives. See Infection by a potentially biohazardous instrument. u Battery power level (39) CoaguChek ProII Operators Manual 2 Putting the Meter into Operation Before using the meter for the first time, perform the following steps:
1. Install the battery pack 2. Connect the power adapter to charge the battery pack 3. Set the current date and time 4. Enter your chosen settings (language, unit of measure, user administration if applicable, etc.) CoaguChek ProII Operators Manual 41 2 n o i t a r e p O o t n i r e t e M e h t g n i t t u P 2 42 2 n o i t a r e p O o t n i r e t e M e h t g n i t t u P 2 2.1 Installing or replacing the battery pack When shipped, the battery pack is not installed in the CoaguChek ProII meter. When the battery pack is not installed, the meter cannot be used. Unused battery packs lose their charge over time and have to be recharged before they can be used. After installing a new battery pack, the meter should be charged at least 4hours before testing, preferably overnight. Whenever the meter is placed on an active Handheld Base Unit or powered by the power adapter, the icon is displayed. This icon shows that power is available and the meter can be charged if necessary. To start the charging process immediately put the meter into standby mode by pressing the On/Off button for approximately 1second. Make sure that the permitted temperature range for charging the battery pack (1232C or 5490F) is maintained during installation and initial setup. Replace the battery pack within approximately 10 minutes to retain the date and time settings. Beyond this period of time, you may have to reenter date and time. Replace the battery pack only in shutdown mode. u To remove the battery pack (45) u 9.2 Shut down / restart / reset meter (189) CoaguChek ProII Operators Manual r To install the battery pack 1 Using the starshaped screwdriver contained in the kit (or another appropriate starshaped screwdriver, e.g. Torx sizeT5), loosen the screws on the battery compartment cover until they are protruding about 45mm (2/10in). 2 Hold the battery pack in your hand, with the wires and the plug pinched between your thumb and index finger. 43 2 n o i t a r e p O o t n i r e t e M e h t g n i t t u P 2 CoaguChek ProII Operators Manual 44 2 n o i t a r e p O o t n i r e t e M e h t g n i t t u P 2 3 Plug the connector plug into the socket. 4 Place the battery pack inside the battery compartment as described in the previous steps. To position the battery pack correctly, always align the ridges on the side of the battery pack with the ridges on the inside of the battery compartment. 5 Place the cover on the battery compartment. Make sure that the plug connector wires do not get pinched between meter and cover the protrusion on the battery compartment cover fits into the corresponding groove on the battery compartment rim 6 Tighten all four screws until snug (do not overtighten). After inserting a new battery pack, the meter powers on automatically. The Roche logo is displayed. If the meter does not power on automatically, the battery pack may be empty. Connect the power adapter for a minimum of 30 minutes, then remove the plug and try to power the meter on. If it powers on, the battery pack is charging properly. Within a short period of time, the start screen should appear. If the meter has been without power for too long, it will show the date and time settings dialog and you have to reenter the date and time settings. The screens for entering the date and the time appear. CoaguChek ProII Operators Manual 7 Enter the date and time. After you have entered the correct information, confirm each screen with
. 8 After installing a new battery pack, the meter should be charged for at least 4hours before testing. r To remove the battery pack CAUTION! Disposal of used battery packs. Do not dispose of the battery pack with normal domestic waste. Dispose of used battery packs in accordance with applicable local regulations and directives and your facilitys guidelines on the disposal of electronic waste equipment. If a battery pack is already installed, make sure that the meter is shut down to prevent damage to the meter or potential data loss. 1 To shut down the meter, remove the external power supply, press the On/Off button 5seconds and release the On/Off button as soon as the Roche logo is displayed and the meter beeps. for about If you press the On/Off button for too long, a meter reset will be triggered after about 12seconds and date and time will be lost. To reset the meter (190) 45 2 n o i t a r e p O o t n i r e t e M e h t g n i t t u P 2 CoaguChek ProII Operators Manual Date09:15 am05/29/2022Year:Month:Day:09:15 am05/29/2022TimeHour:Minute:AMPM 46 2 n o i t a r e p O o t n i r e t e M e h t g n i t t u P 2 2 Place the meter face down on a level surface. 3 Using the starshaped screwdriver contained in the kit (or another appropriate starshaped screwdriver, e.g. Torx sizeT5), remove the four screws holding the battery compartment cover in place. 4 Remove the battery compartment cover from the meter. The battery pack now visible is connected to the meter by a plug. 5 Carefully lift the battery pack and remove the plug connector. CoaguChek ProII Operators Manual 2.2 Powering the meter on and off r To power the meter on and off 1 Place the meter on a level, vibrationfree surface, or hold it in your hand so it is roughly horizontal. 2 Power the meter on by pressing the button
. You can also power on the meter directly by inserting a test strip, connecting the power adapter, or by docking it in the Handheld Base Unit. 3 To power the meter off after use, press the button for approximately 1second. r To check the software version 1 After displaying the Roche logo, the meter briefly displays the Init (for initialization) screen. Here you can check which software version is currently running on your meter. (The Init screen shown here is for illustration purposes only. Version numbers on your meter may differ.) 2 You can also check the current software version in the Diagnostics menu. See 3.7 Diagnostics (108) CoaguChek ProII Operators Manual 47 2 n o i t a r e p O o t n i r e t e M e h t g n i t t u P 2 Init 48 Page intentionally left blank. CoaguChek ProII Operators Manual 3 Meter Setup 3.1 Display of screen elements Note on presentation of screen elements in this manual Buttons are screen prompts that cause something to happen when touched. The names of all buttons are either shown as bold text or as the icon used on the button (e.g., for OK). Other screen elements (e.g., Menu titles) are written in italics. These screen elements are not active. If you have not set the date and time (after powering on for the first time or because the battery pack was removed from the meter for more than 10 minutes), you cannot perform a test. In that case powering on the meter takes you immediately to the Setup mode, where you must set the date and time. After date and time have been set, the meter automatically moves to the Main Menu, where you can start a test or enter more settings. You can open any displayed function by touching (or tapping) the button for it with your finger (or a special pen for this purpose). Tap means: Touch the button, then remove your finger from the touchscreen. The next screen appears once you remove your finger. CoaguChek ProII Operators Manual 49 3 p u t e S r e t e M 3 50 3 p u t e S r e t e M 3 If the meter did not automatically enter the Setup mode
(e.g., after the battery pack was replaced), you can open the Setup Menu from the Main Menu. 1. Touch Setup to open the meter settings. 2. Select the relevant group of settings (see Settings summary following this section). CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnostics 3.2 Settings summary The diagram below shows all of the setup areas that can be accessed on the meter. CoaguChek ProII Operators Manual 51 3 p u t e S r e t e M 3 52 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual SetupScreenOptionsID SetupQC SettingsDiagnosticsContrastParameterConfigurationResultConfirmationLanguageSelectionDate/TimeSortAuto OffConnectionParameterSelectionBeeperDatabaseAdmin.OperatorPatientQC RangeLockouts2 Level QCScan QCMaterialGeneralHardwareError HistoryCertificatesSoftwareMemory UsageWireless SetupScanConfiguration Group Screen Subgroup Setting Result Units PT INR *
INR/SEC INR/%Q Parameter Activation PT *
Contrast Parameter Configuration Result Confirmation Language Selection Date/Time Date Time Date formats
(a) Default settings are labeled with an asterisk (*). CoaguChek ProII Operators Manual 53 Values(a) 0 10 (5 *) PT, aPTT Enable Disable *
etina Dansk Deutsch English *
Espaol Franais Italiano Nederlands Norsk Portugus Suomi Svenska 01/01/2015 *
12:00 am *
DD.MM.YYYY
(01.01.2015) MM/DD/YYYY
(01/01/2015) *
3 p u t e S r e t e M 3 54 3 p u t e S r e t e M 3 Group Subgroup Setting Time formats Options Sort Beeper Beeper Key Click Auto Off
[minutes]
Connection
(a) Default settings are labeled with an asterisk (*). CoaguChek ProII Operators Manual Values(a) YYYYMMDD
(20150101) 24hour time format
(24h) 12hour time format
(12h) with am/pm *
Date/Time *
Patient ID Patient Name Off Low Medium *
High Off *
On Off 1 (5*) 10 15 20 25 30 40 50 60 Off *
Computer Printer Computer/Printer Group Subgroup Setting QR Code Values(a) Off *
On Database Result Retention On (time in days) Off Delete Database Results Remote Service Remote Service WLAN Scan Configuration Parameter Selection Code Chip Data Entire Database On Off On Off Scan Enable Disable *
ID Setup Admin. (Administrator) Blank (Off) *
Operator (Operator List is optional) Inactive *
Active Scan Only/Hidden list No *
Optional Required Scan Only/Hidden list Default Range *
Custom Range Patient QC Settings QC Range PT aPTT
(a) Default settings are labeled with an asterisk (*). CoaguChek ProII Operators Manual 55 3 p u t e S r e t e M 3 56 3 p u t e S r e t e M 3 Group Subgroup Setting Lockouts Operator Lockout
(only if the Operator option is set to Active and an operator list is available) Values(a) Off *
Weekly Monthly Every 3months Every 6months Yearly Number of levels QC Lockout New code (Yes/No) Scheduled (No*, Daily, Weekly, Monthly) Number of hours Number of strips Number of levels: 1/2
(For each option except No) QC Interval Settings Time of day First day of week STAT Test Config. Enable Disable *
Quantity Yes *
No Optional *
Scan Only 2 Level QC Scan QC Material General Software Hardware Diagnostics
(a) Default settings are labeled with an asterisk (*). CoaguChek ProII Operators Manual Group Subgroup Setting Values(a) Memory Usage Error History Wireless Setup Certificates Client Certificate Server Certificates Root CA Certificates Credential Download
(a) Default settings are labeled with an asterisk (*). CoaguChek ProII Operators Manual 57 3 p u t e S r e t e M 3 58 3.3 Screen setup 3 p u t e S r e t e M 3 The Screen setup area contains the options for changing the display. r To set the contrast Use the Contrast menu to adjust the display to your ambient light conditions and make it easier to read. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Screen. 3 From the Screen menu, touch Contrast. If a button is grayed out, this means the function is not available. 4 Touch or from 0 to 10. to change the contrast in a range Contrast 0 makes the display very dark. Contrast 10 makes the display very light. 5 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsScreen09:15 amContrastParameter ConfigurationResult ConfirmationLanguage SelectionDate / Time05/29/202209:15 am05/29/2022ContrastContrast (0-10):
r To configure an additional parameter In the Parameter Configuration menu you can set the units for the display of PT test results and activate additional test parameters on the meter. r To configure the results units for PT Use this setting to select the unit(s) in which the result is displayed. This setting only applies to PT test results. Regardless of the settings chosen for PT, aPTT is always displayed in seconds. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Screen. 3 From the Screen menu, touch Parameter Configuration. 59 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsScreen09:15 amContrastParameter ConfigurationResult ConfirmationLanguage SelectionDate / Time05/29/2022 60 3 p u t e S r e t e M 3 4 From the Parameter Configuration menu, touch Result Units PT. The current unit of measure setting is highlighted
(white type on a blue background). You can select either:
INR INR and seconds INR and Quick value in %
5 Touch the button to select the unit of measure of choice. Your selection is now highlighted. 6 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit r To activate an additional parameter Additional test parameters can be activated on the meter. For doing so you need the corresponding CoaguChek Test Strips with the matching code chip at hand. Available parameters are countryspecific. Only parameters available on the market in the respective country can be activated. The following parameter can optionally be enabled:
aPTT CoaguChek ProII Operators Manual Param. Config.09:15 am05/29/2022Result Units PTParameter ActivationRes. Units PT09:15 am05/29/2022INRINR/SECINR/%QMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsScreen09:15 amContrastParameter ConfigurationResult ConfirmationLanguage SelectionDate / Time05/29/2022 61 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Screen. 3 From the Screen menu, touch Parameter Configuration. 4 From the Parameter Configuration menu, touch Parameter Activation. 5 Insert the code chip from the new box of test strips. The new parameter will now be activated. 6 Touch to confirm the corresponding information message. The display automatically returns to the Parameter Configuration menu. If the Parameter Activation button is grayed out, all available parameters have already been activated on this meter. A parameter that has already been activated on the meter remains activated even after performing a software update. In this case, it can only be disabled via a DMS. r To activate the results confirmation option In some circumstances, it may be useful for operators to confirm the validity of their results. Use this setting to prompt operators to confirm the results of every test. 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual Param. Config.09:15 am05/29/2022Result Units PTParameter ActivationParam. Activat.Insert code chip of the newparameter to activate.09:15 am05/29/2022 62 3 p u t e S r e t e M 3 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Screen. 3 From the Screen menu, touch Result Confirmation. 4 Touch Enable or Disable. Your selection is now highlighted. 5 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit r To select a language Use this setting to select the meter language. 1 From the Main Menu, touch Setup to open the meter settings. CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsScreen09:15 amContrastParameter ConfigurationResult ConfirmationLanguage SelectionDate / Time05/29/2022Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsScreen09:15 amContrastParameter ConfigurationResult ConfirmationLanguage SelectionDate / Time05/29/202209:15 am05/29/2022Result ConfirmationEnableDisableMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsScreen09:15 amContrastParameter ConfigurationResult ConfirmationLanguage SelectionDate / Time05/29/2022 2 From the Setup Menu, touch Screen. 3 From the Screen menu, touch Language Selection. The current language setting is highlighted (white type on a blue background). You can select either:
etina Dansk Deutsch English Espaol Franais Italiano Nederlands Norsk Portugus Suomi Svenska Not all languages are available in all countries. 4 Touch or to display the language of choice on the screen. If the arrow is just an outline reached the end of the list in the respective direction.
, you have 5 Touch the button to select the language of choice. Your selection is now highlighted. 6 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit 63 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual Language09:15 am05/29/2022DanskDeutschEnglishEspaolFranais 64 3 p u t e S r e t e M 3 r To set the date When you power on the meter for the first time (or after a long period without power), the input field for the date automatically appears first. The date
(and time) must be entered before the meter can be used further. If at a later time a date adjustment is needed, go to the Setup Menu, then select the menu of choice. Both Date and Time display formats are controlled by the Format options you select (see Setting the display options for date and time in this chapter). Options shown in the Date and Time menus may vary depending on the chosen formats. You can choose between the following display formats:
Date: Day.Month.Year, e.g., 29.05.2015 Date: Month/Day/Year, e.g., 05/29/2015 Date: YearMonthDay, e.g., 20150529 Time: 24H or 12H 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Screen. 3 From the Screen menu, touch Date/Time. CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsScreen09:15 amContrastParameter ConfigurationResult ConfirmationLanguage SelectionDate / Time05/29/2022 65 4 From the Date/Time menu, touch Set Date. 5 Touch or then the day. to set the year, then the month, 6 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit If this setup menu appeared automatically after powering the meter on, you must touch complete the first date setting. to 7 Touch to return to the Screen menu. r To set the time When you power on the meter for the first time (or after a long period without power), this Time setup menu appears automatically after you set the date. If at a later time a time adjustment is needed, go to the Setup Menu, then select the menu of choice. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Screen. 3 From the Screen menu, touch Date/Time. 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual Set DateSet TimeFormatDate/Time09:15 am05/29/2022Date09:15 am05/29/2022Year:Month:Day:Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsScreen09:15 amContrastParameter ConfigurationResult ConfirmationLanguage SelectionDate / Time05/29/2022 66 3 p u t e S r e t e M 3 4 From the Date/Time menu, touch Set Time. 5 Touch or to set the hours, then the minutes. 6 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit If this setup menu appeared automatically after powering the meter on, you must touch complete the first time setting. to 7 Touch to return to the Screen menu. r To set the date and time format Select your preferred format for the date and time display. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Screen. 3 From the Screen menu, touch Date/Time. CoaguChek ProII Operators Manual Set DateSet TimeFormatDate/Time09:15 am05/29/202209:15 am05/29/2022TimeHour:Minute:AMPMMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsScreen09:15 amContrastParameter ConfigurationResult ConfirmationLanguage SelectionDate / Time05/29/2022 4 From the Date/Time menu, touch Format. The current settings are highlighted. You can select one of the following display formats:
Date: DD.MM.YYYY (Day.Month.Year), e.g., 29.05.2015 Date: MM/DD/YYYY (Month/Day/Year), e.g., 05/29/2015 Date: YYYYMMDD (YearMonthDay), e.g., 20150529 Time: 24H or 12H 5 Touch the button with the display format of choice for date and time. Your selection is now highlighted. 6 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit 7 Touch to return to the Screen menu. CoaguChek ProII Operators Manual 67 3 p u t e S r e t e M 3 Set DateSet TimeFormatDate/Time09:15 am05/29/2022Format09:15 am05/29/2022Date:Time:DD.MM.YYYYMM/DD/YYYYYYYY-MM-DD24H12H 68 3.4 Options setup 3 p u t e S r e t e M 3 r To set the sorting order of lists Sort refers to the order in which measured and stored results are displayed when you use the Review Results function of the CoaguChek ProII meter. You can display stored results chronologically by date and time or by person, based on the Patient ID. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Options. 3 From the Options menu, touch Sort. The current setting is highlighted. You may select from the following sort options:
By Date/Time By Patient ID By Patient Name 4 Touch the button to select the Sort by option of choice. Your selection is now highlighted. Note: The sort option Patient Name is available only when used together with a patient list. Patient lists can only be created with a DMS. For more details see 7.1 Data handling (157) CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsOptionsSortBeeperAuto OffConnectionDatabase09:15 am05/29/2022SortDate / TimePatient IDPatient Name09:15 am05/29/2022Sort By:
5 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit r To enable/disable the beeper option The CoaguChek ProII meter can display information visually and alert you to special circumstances with a Beeper. The meter always beeps when it is switched on. When the Beeper function is enabled the meter beeps once when:
it detects a test strip preheating of the test strip is complete and you need to apply a sample it detects a sample the test is completed and the results are displayed (a long beep) an error occurs (three short beeps) an external power adapter is connected when the meter is on the meter is docked a barcode is scanned We recommend that you keep the Beeper enabled at all times. You can also activate a Key Click. When a Key Click is enabled, the meter clicks briefly every time a button is touched, facilitating the input of information. CoaguChek ProII Operators Manual 69 3 p u t e S r e t e M 3 70 3 p u t e S r e t e M 3 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Options. 3 From the Options menu, touch Beeper. The current setting is highlighted. 4 You may select from the following options for the Beeper:
Off Low Medium High 5 You may select from the following options for the Key Click:
On Off 6 Touch the button with the desired setting for the Beeper, then touch the button with the setting of choice for the Key Click. Both selections are now highlighted. 7 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsOptionsSortBeeperAuto OffConnectionDatabase09:15 am05/29/202209:15 am05/29/2022BeeperOffLowMediumHighOnOff r To enable the auto off option You can set up your CoaguChek ProII meter so that it powers itself off automatically if it has not been used (no buttons touched or tests run) for a preselected time period. Use this feature to save power and extend the life of the battery pack. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Options. 3 From the Options menu, touch Auto Off. If the meter is connected to the power adapter or the Handheld Base Unit, the Auto Off function has a different effect:
The meter powers itself off after 10 minutes without user interaction, regardless of the selected settings. 4 You may select from the following options:
Off (meter never powers itself off) Time until meter powers itself off: 110, 15, 20, 25, 30, 40, 50, 60minutes 71 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsOptionsSortBeeperAuto OffConnectionDatabase09:15 am05/29/2022 72 3 p u t e S r e t e M 3 5 Touch or to select the time of choice in minutes or to switch the feature off. 6 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit r To open the connection menu In the Connection menu you can configure the data exchange with external devices. The meter can be connected:
to a computer (DMS) only or to a printer only or to both a computer (DMS) and a printer In addition to this direct data output, test results may also be encoded as QR codes, which can be scanned to be used with other applications. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Options. 3 From the Options menu, touch Connection. CoaguChek ProII Operators Manual Auto OffMinutes:09:15 am05/29/2022Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsOptionsSortBeeperAuto OffConnectionDatabase09:15 am05/29/2022 73 r To enable/disable the QR Code display 1 From the Connection menu (see section above), touch QR Code. To open the connection menu (72) 2 Touch On to enable, or touch Off to disable QR code display. Your selection is now highlighted. 3 If you have enabled this feature, select the style of the QR code to be displayed:
Plain Text: Use this option to scan the result into a PC hosted application (e.g. electronic medical record). In order to do so, you need an external 2Dbarcode scanner attached to your PC. Once scanned, the test result and related metainformation (e.g. date, time, comments) will appear as plain text in your PC application. Ensure that your environment for reading QR codes (QR code reader, operating system, text processing application) is appropriate for your language. Disregard may lead to unpredictable behavior of your receiving component (PC, mobile device). Coded Data: Use this option to scan the result into a smartphone or tablet app, or a PC hosted application. URL Transmission: Use this option to upload the result to a web based service (e.g. such as an electronic health record, coagulation management software, etc.). For this option further parameters (URL, encryption key) must be set. Note: For the options Coded Data and URL 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual Connection09:15 am05/29/2022QR CodeOffComputerPrinterComputer/PrinterQR CodeShow QR code:OnOffPlain TextCoded DataURL Transmission05/29/202209:15 am 74 3 p u t e S r e t e M 3 Transmission dedicated software programs or apps are required in order to use this feature. If you are a customer or a 3rd party IT provider, and you are interested to use this feature, contact your local Roche Diagnostics representative for additional information. 4 Touch Plain Text, Coded Data or URL Transmission, depending on the intended use. Your selection is now highlighted. If you have selected URL Transmission, the button will become active. Use this button to set the additional parameters. 5 Touch to open the URL Transmission menu. 6 Touch URL to enter the URL to which the test result data will be uploaded (note: the URL will be provided by your specialized service provider). Use to switch to input of numbers. Use to switch back to input of text. Use to backspace and correct a mistake. 7 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit 8 Touch Encryption Key to display the Encryption Key menu. The Encryption Key menu displays two types of information which are required in order to identify and decode the transmitted test result. This information is required by the IT system, to which the test result is transmitted via the defined URL. This information needs to be exchanged once with your specialized service provider prior to CoaguChek ProII Operators Manual QR CodeShow QR code:OnOffPlain TextCoded DataURL Transmission05/29/202209:15 amURL Transmission09:15 am05/29/2022URLEncryption KeyURL09:15 am123ABCURL Transmission09:15 am05/29/2022URLEncryption KeyEncryption KeyKey:Serial No.:Note: The encryption key and theserial number are required todecrypt QR code messages fromthis meter. Ensure they areavailable on the target system.09:15 am05/29/2022 75 using the URL transmission method. Contact your specialized service provider in order to exchange this information. Key: This key is autogenerated by the meter and is required to decrypt the QR code information. Serial No.: The meter's serial number is required to map the test result to the encryption key. Touch the New button, if you want the meter to generate a new encryption key. 9 Touch twice to return to the QR Code menu. 10 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit r To connect to the computer The CoaguChek ProII meter can connect with a computer or host system running appropriate software (that is, a DMS must be installed). To use this connectivity feature, however, you need the optional Handheld Base Unit or the meter must be configured for wireless communication. See C.1 Option: Wireless network (WLAN) (211) If no wireless communication is configured, the connection is established in two steps. The meter connects to the Handheld Base Unit via infrared. The Handheld Base Unit is either connected to a single computer (via USB) or to a network/host system (via ethernet). This function can be activated by selecting Computer or Computer/Printer. Select Computer/Printer if you want to activate both 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual 76 3 p u t e S r e t e M 3 functions at the same time. The option Computer or Computer/Printer (when activated) can be used together with a DMS to set up:
operator lists, or patient lists (lists of patients to be tested) This eliminates the need for manual entry of these data. In addition, you can transfer test results stored in the meter to other systems for archiving or further evaluation. The option Computer or Computer/Printer controls the meters ability to communicate with a computer or a network and/or with a printer. 1 From the Connection menu, touch Computer or Computer/Printer. Your selection is now highlighted. Touch To open the connection menu (72)
. If you are using a DMS, from the TLS screen you may select On or Off for the following options:(1) TLS Encryption:
Set to On to activate an end-to-end TLS tunnel from the meter to the DMS TLS Authentication:
Set to On to ensure that the end-to-end TLS tunnel is only initiated between an authenticated meter and an authenticated DMS TLS (Transport Layer Security) supports many different methods for exchanging keys, encrypting data and authenticating message integrity. Using the TLS encryption and authentication options activates an end-to-end TLS tunnel from meter to
(1) TLS authentication is only configurable, if TLS encryption is enabled. CoaguChek ProII Operators Manual Connection09:15 am05/29/2022QR CodeOffComputerPrinterComputer/Printer09:15 am05/29/2022TLSTLS Encryption:TLS Authentication:OnOnOffOff 77 DMS. This is the most effective measure to achieve secure communication. It is recommended to activate these configurations. 2 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit Extended data handling functionality is dependent on the capabilities of the particular Data Management System (DMS) being used and may vary. r To connect to the printer The CoaguChek ProII meter can also connect directly to a printer. This function can be activated by selecting Printer or Computer/Printer. Select Computer/Printer if you want to activate both functions at the same time. To use the printing feature, you need an optional infrared printer. 1 From the Connection menu, touch Printer or Computer/Printer. Your selection is now highlighted. Touch To open the connection menu (72)
. If you selected the Computer/Printer option and you are using a DMS, from the TLS screen you may select On or Off for the following options:(2) TLS Encryption:
Set to On to activate an end-to-end TLS tunnel from the meter to the DMS 3 p u t e S r e t e M 3
(2) TLS authentication is only configurable, if TLS encryption is enabled. CoaguChek ProII Operators Manual Connection09:15 am05/29/2022QR CodeOffComputerPrinterComputer/Printer09:15 am05/29/2022TLSTLS Encryption:TLS Authentication:OnOnOffOff 78 3 p u t e S r e t e M 3 TLS Authentication:
Set to On to ensure that the end-to-end TLS tunnel is only initiated between an authenticated meter and an authenticated DMS TLS (Transport Layer Security) supports many different methods for exchanging keys, encrypting data and authenticating message integrity. Using the TLS encryption and authentication options activates an end-to-end TLS tunnel from meter to DMS. This is the most effective measure to achieve secure communication. It is recommended to activate these configurations. 2 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. To print:
to exit Align the meter with the IR printer. At any test or memory screen, touch
. The printer icon only appears if the printer function is activated. Otherwise it is not displayed. If you work with the meter in a language other than English: With the exception of information you have entered such as patient ID and name, operator ID, comments the printout will be in English. See To select a language (62) r To configure the database You can set up your CoaguChek ProII meter so that the results are retained on the database for a preselected time period. Use this feature to automatically clear the database CoaguChek ProII Operators Manual 09:15 am05/29/2022P-ID:Op:Par:PID01Smith, HenryOperator 1PTCode:18411/14/2021 07:30 amINR%Q2.521Doctor NotifiedSickTravelMemory periodically. If you do not use this feature, then you will be required to delete data manually or save the data on a data management system. If the memory is full when you perform a test, the oldest result is automatically deleted. The most recent result is always saved. This applies both to patient results and to quality control tests. In order to avoid the loss of stored test results, you can archive this data using a data management system and the optional Handheld Base Unit (see Chapter 7). 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Options. 3 From the Options menu, touch Database. You may select from the following options:
Result Retention Delete Database 79 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual OptionsSortBeeperAuto OffConnectionDatabase09:15 am05/29/2022Setup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupDatabase09:15 am05/29/2022Result RetentionDelete Database 80 3 p u t e S r e t e M 3 4 Touch the button to select the database option of your choice. Your selection is now highlighted. If you selected Result Retention you may choose the following options:
On: Deletes results automatically after a preselected time period. Using the number of days you would like to retain the data. or
, select Off: Results are not automatically deleted. Regular cleaning up of the database is manually required. f Note: Meter default is 30. 5 If you selected Delete Database, you may select from the following options depending on which type of data you would like to delete:
Results Code Chip Data Entire Database 6 Touch to return to the Database screen. r To enable/disable the remote service option 1 The meter can be configured to connect to a remote service, e.g., for device registration or for receiving software updates. CoaguChek ProII Operators Manual Result Retention09:15 am05/29/2022Delete resultsautomatically:Retention time in days:OnOff09:15 am05/29/2022ResultsCode Chip DataEntire DatabaseDelete DatabaseMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsOptionsSortBeeperAuto OffConnectionDatabase09:15 am05/29/202209:15 am05/29/2022Remote ServiceScan ConfigurationParameter SelectionOptions 2 From the Main Menu, touch Setup to open the meter settings. 3 From the Setup Menu, touch Options. 4 Use and to toggle between the screens. 5 From the 2nd Options menu, touch Remote Service. 6 You may select On or Off for the following options:
Remote service communication: enable or disable communication with cobas infinity edge via the remote service gateway. Requires WLAN to be enabled. WLAN communication: allow communication via WLAN (On) or only via the Handheld Base Unit
(Off). This may be DMS communication as well as using a remote service. Meter registered: the meter has successfully registered with the remote service. 7 Touch to save this setting, or touch this menu without saving any changes. to exit r To scan a configuration barcode 1 If the meter is configured to connect to a remote service, the required connection parameters can simply be scanned from a barcode provided by the remote service (e.g., cobas infinity edge). 81 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual 09:15 am05/29/2022OnOnOffOffRemote ServiceRemote servicecommunication:WLANcommunication:Meter registered:Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsOptionsSortBeeperAuto OffConnectionDatabase09:15 am05/29/202209:15 am05/29/2022Remote ServiceScan ConfigurationParameter SelectionOptions 82 3 p u t e S r e t e M 3 2 From the Main Menu, touch Setup to open the meter settings. 3 From the Setup Menu, touch Options. 4 Use and to toggle between the screens. 5 From the 2nd Options menu, touch Scan Configuration. 6 Point the built-in barcode scanner to the barcode provided by the remote service (e.g., on the computer monitor). 7 Touch Scan and scan the configuration barcode from a distance of approx. 10-20cm (4-8 inches), according to the barcode size. 8 Confirm the information message following the barcode scan and touch afterwards. to exit this screen r To enable/disable the parameter selection option When performing a test, the meter can be set to display a screen that allows the operator to select the test parameter to be used. Otherwise the meter will determine the test parameter by reading the test strip (barcode) information from the inserted test strip. The Parameter Selection button is only available, if more than one parameter has been activated on this meter. See To activate an additional parameter (60) CoaguChek ProII Operators Manual 09:15 am05/29/2022Scan a new configurationbarcode.ScanScan Config. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Options. 3 Use and to toggle between the screens. 4 From the 2nd Options menu, touch Parameter Selection. 5 Touch Enable to display the parameter selection screen prior to each test or touch Disable to have the meter select the parameter by reading the test strip information. 6 Touch to save this setting, or touch this menu without saving any changes. to exit 83 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsOptionsSortBeeperAuto OffConnectionDatabase09:15 am05/29/202209:15 am05/29/2022Remote ServiceScan ConfigurationParameter SelectionOptionsSelect Param.09:15 am05/29/2022EnableDisable 84 3.5 ID setup 3 p u t e S r e t e M 3 Use the ID Setup menu to enter settings for user management and patient management. These settings are optional and set to Off/Inactive by default; the meter can be operated without these settings. There are three types of identification used with the meter:
System Administrator: The Admin.
(Administrator) has special rights to enter certain meter settings and is the only one who can enter and change these settings. It is not necessary for Admin. identification to be activated to use the CoaguChek ProII meter. However, it might be desired or necessary, depending on the regulatory environment and the site of use. Operator: The Operator ID is assigned to persons who use the meter to run tests. If you want to use Operator IDs, you have several options:
You may use Operator IDs to restrict the use of the meter to qualified personnel or a predefined group of users. In this case an operator list created externally must be transferred to the meter, enabling you to select an Operator ID when logging in. For more details see Data handling. You may use Operator IDs for informational purposes only, in order to assign stored measurement results to the users who performed the test. In this case Operator IDs may be entered directly on the meter (by keypad or scanner), with or without an operator list being available. Patient: The Patient ID is assigned to the person, whose test results are recorded. You can either:
CoaguChek ProII Operators Manual block input of a unique Patient ID (in this case, every test is simply numbered in consecutive order) allow a unique Patient ID as optional, or require a unique Patient ID for every test. Patient lists created externally can also be transferred to the meter, enabling you to select a Patient ID for a test from these lists. For more details see Data handling. u 7.1 Data handling (157) Operator IDs can be selected from a list (if available) or read by the barcode scanner on the side of the meter. If passwords were created, they must be entered via the onscreen keypad. Patient IDs can be entered by using the onscreen keypad or the barcode scanner on the side of the meter. For more information on working with operator and patient ID barcodes, see Data handling. u 7.1 Data handling (157) The buttons in the ID Setup menu show what the current settings are (this is just an example, the screen may look different on your meter):
The standard display of the Admin. button means the function is available but not activated (a password for the system administrator/supervisor has not been assigned). The standard display of the Operator button means the Operator login is available but not activated. When the Patient button is highlighted (that is, when it has a blue background) this means the function is available and activated (either as Optional or Required). 85 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual ID SetupAdmin.OperatorPatient09:15 am05/29/2022 86 System Administrator (Admin.) In the default setting, the meter is not protected with an Admin.ID, and all setup options are accessible to every user. If you set up an Admin.ID, the following setup areas are automatically reserved only for the system administrator/ supervisor (i.e., the person who knows the password). Screen: Parameter Configuration, Result Confirmation, Date/Time Options: Connection (to a computer or a printer), Remote Service and Scan Configuration ID Setup (the entire area) QC Settings (the entire area) Diagnostics: Software, Hardware, Memory, Wireless Setup, Certificates When you enter an Admin.ID, this ID will have to be entered from this point forward before any of the settings above can be changed. The Admin.ID must also be entered before you can delete or change the Admin.ID itself. If you forget the Admin.ID, contact your Roche Diagnostics representative. r To configure an Admin. ID 3 p u t e S r e t e M 3 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch ID Setup. CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsAdmin.OperatorPatient09:15 am05/29/2022ID Setup 3 From the ID Setup menu, touch Admin. 4 Using the keypad displayed on the screen, enter the Admin. ID of choice. The ID can consist of up to 20 characters. Pay close attention to the buttons you press, because the characters are not displayed on the screen. Asterisks are displayed instead (as if entering a password on a computer). 5 Use to switch to input of numbers. 6 Use to switch back to input of text. 7 Use to backspace and correct a mistake. 8 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit 9 Enter the Admin. ID again (the keypad is automatically displayed again on the screen) to confirm the first entry. 10 Touch to save this entry, (the Admin. ID is now to exit this menu without saving any set), or touch changes. The Admin. ID is not set and is therefore still inactive. The display automatically returns to the ID Setup menu. After you exit the Setup Menu, only an CoaguChek ProII Operators Manual 87 3 p u t e S r e t e M 3 09:15 amAdmin.12309:15 amAdmin.ABC09:15 amAdmin. 88 3 p u t e S r e t e M 3 authenticated administrator may further edit the setup areas as listed before. See System Administrator (Admin.) (86) r To change an Admin. ID 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch ID Setup. 3 Using the keypad displayed on the screen, enter the current Admin. ID. The ID Setup menu is displayed. The Admin. button is highlighted, which means an Admin. ID is active. 4 Touch Admin. 5 Using the keypad displayed on the screen, enter
(and confirm) the new Admin. ID of choice. r To deactivate an Admin. ID CoaguChek ProII Operators Manual Admin.OperatorPatient09:15 am05/29/2022ID SetupMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnostics09:15 amAdmin.Admin.OperatorPatient09:15 am05/29/2022ID SetupMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnostics09:15 amAdmin. 89 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch ID Setup. 3 Using the keypad displayed on the screen, enter the current Admin. ID. The ID Setup menu is displayed. The Admin. button is highlighted, which means an Admin. ID is active. 4 Touch Admin. 5 Immediately touch to close the keypad on the screen without entering a password. The Admin. ID has been deleted and therefore deactivated. The Admin. button is no longer highlighted. Operator ID If you want to create a list of Operator IDs from which you can select an operator, additional software (a data management system) and the Handheld Base Unit are required (see Data handling). u 7.1 Data handling (157) In the default setting, the Operator login is not activated. You can either activate or deactivate Operator login on the meter. If activated, an Operator has to log in before the Main Menu will be displayed and measurements can be performed. 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual Admin.OperatorPatient09:15 am05/29/2022ID Setup09:15 amAdmin. 90 r To activate an operator ID 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch ID Setup. 3 From the ID Setup menu, touch Operator. 4 Touch the button with the setting of choice for setting up the Operator login. Your selection is now highlighted. 5 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit Patient ID 3 p u t e S r e t e M 3 If you want to create a list of Patient IDs from which you can select a patient for testing, additional software (a data management system) and the Handheld Base Unit are required (see Data handling). CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsAdmin.OperatorPatient09:15 am05/29/2022ID SetupInactiveActiveOperator ID09:15 am05/29/2022 u 7.1 Data handling (157) In the default setting, input of Patient IDs is set to No. This means each test is simply assigned a consecutive number. However, you can require that a Patient ID be entered or make it optional. r To activate a patient ID 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch ID Setup. 3 From the ID Setup menu, touch Patient. You may select from the following options:
No (tests will be assigned numbers automatically) Optional (automatic numbering or list/scan/
manual input) Required (list/scan/manual input) 4 Touch the button with the setting of choice for setting up the Operator login. Your selection is now highlighted. 91 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsAdmin.OperatorPatient09:15 am05/29/2022ID Setup 92 3 p u t e S r e t e M 3 5 Touch to save this setting, or touch this menu, without saving any changes. to exit The settings for the option No are now completed. For the options Optional and Required, continue by selecting the input format. 6 Select the form for input of the Patient ID. You may select from the following options:
Alphanumeric: Enter any combination of letters and numbers, e.g., J. DOE3378. Numeric: Enter numbers only, e.g., 3387. Min. Length: Enter the minimum number of characters (1 20) the Patient ID must have. Max. Length: Enter the maximum number of characters (1 20) the Patient ID can have. 7 Touch the button with the format of choice for the Patient ID. Your selection is now highlighted. 8 Touch or to set the number of characters
(length) of choice. 9 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit CoaguChek ProII Operators Manual Patient IDNoOptionalRequired09:15 am05/29/2022Patient IDAlphanumericNumericMin. Length:Max. Length:09:15 am05/29/2022 3.6 QC Settings setup QC Settings overview QC Range Lockouts (QC Lockout and Operator Lockout) The QC Settings menu contains options for enforcing the performance of liquid quality controls by the operator at specified intervals. It also provides the option of customizing the QC Range in accordance with applicable local guidelines. The QC Settings menu contains options for enforcing the performance of liquid quality controls by the operator at specified intervals. It also provides the option of customizing the QC Range in accordance with applicable local guidelines. There are two options:
Default Range: The meter displays the QC Range provided by Roche Diagnostics in the code chip. Custom Range: The option Custom Range lets the user define their own QC Range within the default range. If the liquid quality control test is not performed correctly, or if the result is outside the target value range, the meter is locked from further use. The Lockout can also be set up selectively for individual operators. A liquid quality control test must be completed successfully before the meter is available again for testing (either by the operator or in general). 93 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual 94 3 p u t e S r e t e M 3 2 Level QC Scan QC Material QC Range The option of setting up an Operator Lockout is available only when operator lists are created on a data management system (DMS), stored in the meter, and Operator login is activated. These lists are only available in connection with a data management system. For more details see Data handling. u 7.1 Data handling (157) With this option you can configure a continuous 2level liquid quality control test, if the test has two levels. The second test will start immediately after successfully finishing the test for one level. If disabled, the meter returns to the Main Menu once one of the two levels has successfully been tested. The barcode scanner of the CoaguChek ProII meter can be used to scan barcodes from QC material vials. This function can be set to Optional or Scan Only. When set to Scan Only, the operator will not be able to manually select a QC lot number from a list. Liquid quality control ranges can be customized to comply with local guidelines. The QC Range function enables you to narrow the default range for the test parameter. CoaguChek ProII Operators Manual r To set a QC range 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch QC Settings. 3 From the QC Settings menu, touch QC Range. 4 From the QC Range menu, touch the button of the test parameter you wish to set. You may select from the following options:
Default Range (Range provided in the code chip is selected and displayed. No target value is displayed.) Custom Range (The allowed percentage deviation from target value can now be customized. Additionally, you can choose between displaying the target value along with a control test result or not displaying the target value with the control test result.) 5 Touch the button with the setting of choice. Your selection is now highlighted. If you selected Default Range, touch save this setting, or touch without saving any changes. to to exit this menu 95 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsQC SettingsQC RangeLockouts2 Level QCScan QC Material09:15 am05/29/202209:15 am05/29/2022aPTTPTQC Range09:15 am05/29/2022QC RangeDefault RangeCustom RangePar:aPTT 96 3 p u t e S r e t e M 3 If you selected Custom Range, touch proceed with corresponding settings, or touch to to exit this menu without saving any changes. The display automatically returns to the previous screen. If you selected Custom Range, the QC Range screen opens and offers you the following options:
Display target value (On/Off) Deviation from target value (percentage value). See QC Range (94) For the control solutions, the target value always comes from the information stored in the code chip. If you have chosen Custom Range, you can now select an allowed deviation from target value in the range of 0 to 22.5% (in the illustration, 11.5%). Note: For the test parameter PT, the percentage deviation from the target value is always defined using INR values. Even if you have activated %Quick in the setup, the meter always calculates the deviation using INR values; This range is then converted to %Quick in a second step. As there is no linear correlation between values expressed as INR and values expressed as %Quick, if you calculate the percentage deviation (11.5% in the example) using the
%Quick target value, your result may deviate from the result calculated by the meter using the INR target value. CoaguChek ProII Operators Manual 09:15 am05/29/2022QC RangeDefault RangeCustom RangePar:aPTT09:15 am05/29/2022QC RangeCustom RangeDisplay targetvalueDeviation from target valueOnOff 6 Touch On (the target value will be displayed with a test result) or Off (the target value will not be displayed). Your selection is now highlighted. 7 Use the arrows to set the allowed percentage deviation from the target value. Use the arrows on the left to adjust the number before the decimal point. Use the arrows on the right to adjust the number after the decimal point. 8 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the QC Settings screen. to exit If the Custom Range and Target Value are set to On, they appear in a line below the control test result in the QC test and QC memory screens. The target value (2.9) appears in front of the custom range. If the Display target value is set to Off, only the Custom Range is displayed below the control test result. CoaguChek ProII Operators Manual 97 3 p u t e S r e t e M 3 09:15 am05/29/2022QC RangeCustom RangeDisplay targetvalueDeviation from target valueOnOffOp:Par:Code:184PT09:15 am05/29/2022Operator 1QC Test999QC:Level:202/10/2022 08:30 amINRPass:(2.9, 2.6 - 3.2 INR)16 %Q(17, 16 - 20 %Q)3.0Op:Par:Code:184PT09:15 am05/29/2022Operator 1QC Test999QC:Level:202/10/2022 08:30 amPass:INR(2.6 - 3.2 INR)16 %Q(16 - 20 %Q)3.0 98 QC (quality control) Lockout QC Lockout ensures that the optional quality control tests are run on a regular basis. This is independent of the operator, however. This option should be used if you work without operator lists. QC Lockout is disabled by default. For routine confirmation of system reliability it is recommended to enable this feature. It is also possible to enable Operator Lockouts and QC Lockouts in parallel. In addition to defining time intervals or numbers, QC Lockout can also be used to specify that a quality control test must be carried out when a new test strip lot is used (New Code). The lockout triggers are set once and are valid for all parameters. The events (time intervals, numbers) triggering the lockouts are counted individually for each parameter. The lockout triggers based on counters (number of hours or strips) can be reset at any time (before the counter reaches the limit) by performing a quality control test. The counter will be reset once the quality control test has successfully been finished. 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual 99 r To set a QC (quality control) Lockout 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch QC Settings. 3 From the QC Settings menu, touch Lockouts. 4 From the Lockouts menu, touch QC Lockout. 5 Select the triggers for a quality control test, based on lot and/or time or number of strips. 6 You may select from the following options:
New Code Yes/No (applies every time a new test strip lot is used). The general intervals are:
No Daily Weekly No. of Hours No. of Strips 7 Touch the button with your chosen option when changing the test strip lot. 8 Touch or to display the interval of choice on the screen. 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual LockoutsQC LockoutOperator LockoutQC Interval SettingsSTAT Test Config.09:15 am05/29/2022Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsQC SettingsQC RangeLockouts2 Level QCScan QC Material09:15 am05/29/2022New Code09:15 am05/29/2022YesWeeklyMonthlyNoNo. of HoursNo. of StripsQC LockoutNew CodeQC Lockout09:15 am05/29/2022NoYesDailyWeeklyMonthlyNo 100 For additional setup options of date based intervals
(Daily, Weekly, Monthly), see QC Interval Settings (103) 9 Touch the button to select the interval of your choice. Your selection is now highlighted. 10 Touch to proceed, or touch to exit this menu without saving any changes. 11 If you have selected either No. of Hours or No. of Strips, enter the corresponding number now. 12 Touch to proceed, or touch to exit this menu without saving any changes. 13 For every option except for No, you must now indicate the number of levels at which the quality control must be performed. 14 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit Operator Lockout 3 p u t e S r e t e M 3 Optional liquid quality controls can be used to ensure that an operator is performing tests properly on the CoaguChek ProII meter. CoaguChek ProII Operators Manual New Code09:15 am05/29/2022YesWeeklyMonthlyNoNo. of HoursNo. of StripsQC LockoutNumber of strips (1-999):QC Lockout09:15 am05/29/202209:15 am05/29/2022Op. LockoutOne LevelTwo LevelsNumber of Levels The Operator Lockout function constrains an operator, who has been set up in the list, to perform these quality controls on a regular basis. r To set an operator lockout 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch QC Settings. 3 From the QC Settings menu, touch Lockouts. 4 From the Lockouts menu, touch Operator Lockout. If this button is disabled (grayed out), either no operators have been set up or the Operator ID option has been deactivated. Note: The option of setting up an Operator Lockout is available only when operator lists are created on the DMS. For more details see 7.1 Data handling
(157) If you are not working with a DMS, only the QC Lockout is available. See QC (quality control) Lockout (98) 101 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual LockoutsQC LockoutOperator LockoutQC Interval SettingsSTAT Test Config.09:15 am05/29/2022Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsQC SettingsQC RangeLockouts2 Level QCScan QC Material09:15 am05/29/2022 102 3 p u t e S r e t e M 3 5 Select the interval of choice in which the mandatory quality control tests must be performed. You may select from the following options:
No (deactivated) Weekly Monthly Every 3 Months or Every 6 Months Yearly 6 Touch or to display the interval of choice on the screen. 7 Touch the button to select the interval of your choice. Your selection is now highlighted. 8 Touch to proceed, or touch to exit this menu without saving any changes. 9 For every option except for No, you must now indicate the number of levels at which the quality control must be performed. 10 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit CoaguChek ProII Operators Manual Op. Lockout09:15 am05/29/2022NoWeeklyMonthlyEvery 3 MonthsEvery 6 MonthsOp. Lockout09:15 am05/29/2022WeeklyMonthlyEvery 3 MonthsEvery 6 MonthsYearly09:15 am05/29/2022Op. LockoutOne LevelTwo LevelsNumber of Levels QC Interval Settings For all lockouts based on date intervals (Daily, Weekly, Monthly) the time of occurrence can be set, and for weekly lockouts also a preferred day of the week. r To set the QC interval settings 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch QC Settings. 3 From the QC Settings menu, touch Lockouts. 4 From the Lockouts menu, touch QC Interval Settings. 5 Select the Time of day and First day of week for the lockout to be triggered. The setting for Time of day applies to all lockouts based on date intervals. The setting for First day of week applies to lockouts in weekly intervals only. CoaguChek ProII Operators Manual 103 3 p u t e S r e t e M 3 LockoutsQC LockoutOperator LockoutQC Interval SettingsSTAT Test Config.09:15 am05/29/2022Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsQC SettingsQC RangeLockouts2 Level QCScan QC Material09:15 am05/29/2022 104 3 p u t e S r e t e M 3 6 Touch or to enter the desired time and day. 7 Touch to save this setting, or touch this menu without saving any changes. The display automatically returns to the previous screen. to exit STAT Test Configuration Quality control tests ensure consistent quality and accurate measurements. In emergency situations, however, it may be necessary to perform a test without delay. To override an active lockout(3), you can allow STAT Tests (STAT=ShortTurnAround Time). You can set the number of tests (up to nine) permitted beyond the lockout. Once the number of STAT Tests allowed has been reached, additional tests cannot be performed until you have successfully completed a quality control test. The default setting is three STAT tests. The results of STAT tests are always identified by the label STAT Test when they are displayed. u To perform a STAT test (130) The number of STAT tests performed is counted per test parameter used. Once the maximum number of STAT tests has been reached, this parameter cannot
(3) QC, operator, or new lot lockout CoaguChek ProII Operators Manual QC Int. SettingsTime of day:Hour:Minute:First day of week:AMPMWed09:15 am05/29/2022 be tested without performing a control test first. Other test parameters that have not yet reached this limit are still available. r To enable/disable the STAT test option 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch QC Settings. 3 From the QC Settings menu, touch Lockouts. 4 From the Lockouts menu, touch STAT Test Config. 5 Touch Enable to allow STAT Tests or touch Disable to prohibit STAT Tests. Your selection is now highlighted. 6 If you have enabled the option, touch set the number of additional tests. or to 7 Touch to save this setting, or touch this menu without saving any changes. to exit 2 Level QC With this option you can configure a continuous 2level quality control test, if the test has two levels. CoaguChek ProII Operators Manual 105 3 p u t e S r e t e M 3 LockoutsQC LockoutOperator LockoutQC Interval SettingsSTAT Test Config.09:15 am05/29/2022Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsQC SettingsQC RangeLockouts2 Level QCScan QC Material09:15 am05/29/2022STAT TestEnableDisable09:15 am05/29/2022 106 3 p u t e S r e t e M 3 r To enable 2 level QC 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch QC Settings. 3 From the QC Settings menu, touch 2 Level QC. 4 Touch Yes to automatically start the test for the second level once the test for one level has been finished successfully. Or touch No to finish the test after one level and return to the Main Menu. Your selection is now highlighted. 5 Touch to save this setting, or touch this menu without saving any changes. to exit Scan QC Material The barcode scanner of the CoaguChek ProII meter can be used to scan barcodes from QC material vials. CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsQC SettingsQC RangeLockouts2 Level QCScan QC Material09:15 am05/29/20222 Level QC09:15 am05/29/2022YesNoPerform two control tests in a rowif a QC has two levels?
r To use the scan QC material option 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch QC Settings. 3 From the QC Settings menu, touch Scan QC Material. 4 Touch Optional to allow manual selection of a QC lot number from a list or touch Scan Only to prohibit manual selection. Your selection is now highlighted. 5 Touch to save this setting, or touch this menu without saving any changes. to exit 107 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupSetup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsQC SettingsQC RangeLockouts2 Level QCScan QC Material09:15 am05/29/2022Scan QC Mat.OptionalScan Only09:15 am05/29/2022 108 3.7 Diagnostics Under Diagnostics, you will find information about the system, such as software version, number of data records stored, and configuration details. The diagnostics screens shown here are for illustration purposes only. The Information shown on your meter may differ. r To display the diagnostics screens 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup Menu, touch Diagnostics. 3 From the Diagnostics menu, touch the button of the diagnostics screen you want to display. Use screens. and to toggle between the diagnostics 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual Wireless SetupCertificatesDiagnostics09:15 am05/29/2022Setup Menu09:15 am05/29/2022ScreenOptionsID SetupQC SettingsDiagnosticsMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetup09:15 am05/29/2022GeneralSoftwareHardwareMemory UsageError HistoryDiagnostics 109 4 Use and to toggle between the Wireless Setup screens. 5 From the Certificates menu, touch the button of the certificates screen you want to display. 3 p u t e S r e t e M 3 CoaguChek ProII Operators Manual 09:15 am05/29/202203/12/2022 08:00 am02/10/2022 08:30 am11/14/2021 07:30 am10/10/2021 07:05 am01/02/2022 10:17 amError HistoryClientSubject:Validity:Fingerprint:New09:15 am05/29/202209:15 am05/29/2022Server09:15 am05/29/2022Subject:Validity:Fingerprint:ServerCertificatesClient CertificateServer CertificatesRoot CA Certificates09:15 am05/29/2022Credential DownloadRoot CAs09:15 am05/29/2022Root CAsSubject:Validity:Fingerprint:09:15 am05/29/2022Meter name:Home location:Last synchronization:05/29/2022Non-transmitted results:Meter:New Lot:Operator:03/12/2022 08:00 amactivein lockout09:15 am05/29/2022General09:15 am05/29/2022HardwareSerial no.:HBM HW:MM HW:Battery Voltage:Battery Percent:Battery Condition:GoodMemory UsagePatient Tests:in use/max. (no.):Control Tests:09:15 am05/29/2022Patient List:Operator List:Tests until lifetime end:in use/max. (no.):in use/max. (no.):in use/max. (no.):SoftwareBuild:Boot:Kernel:Rootfs:App:MM-BL:MM-FW:09:15 am05/29/2022Wireless Setup09:15 am05/29/2022Wireless Setup - ConnectionDMS Name:DMS Port Number:DMS IP Address:POCT Server4711192.168.3.214712192.168.3.24RSG Name:RSG Port Number:RSG IP Address:WPA2-PSK (AES)09:15 am05/29/2022Wireless SetupWireless Setup - Test DMSRF activated:Associated:Authenticated:Received IP:IP:Subnet:Gateway:DNS:Contacted DMS:Connected to DMS:Completed:Test192.168.3.21255.255.255.0RF Standard:WPA2Wireless Setup09:15 am05/29/2022Wireless Setup - NetworkUse DHCP:Use DNS:SSID:WLAN:MAC:1A 3E B6 78 9C AFSSID123456RF Security:WPA2-PSK (AES)EnabledDisabled09:15 am05/29/2022Wireless SetupWireless Setup - Test RSGRF activated:Associated:Authenticated:Received IP:IP:Subnet:Gateway:DNS:Completed:Test192.168.3.21255.255.255.0192.168.3.24192.168.3.1RF Standard:WPA2Contacted RSG:09:15 am05/29/2022Cred. DownloadTo download meter credentials,place meter in Handheld BaseUnit and press the downloadbutton.PIN 110 3 p u t e S r e t e M 3 6 In the diagnostics screen, touch to return to the previous menu. CoaguChek ProII Operators Manual 4 Testing a Blood Sample 111 4.1 Important notes What you need:
Always... CoaguChek ProII meter Test Strips with matching code chip
(see section "What can the system do for you?") When testing with venous blood:
Standard blood collection device (syringe) When testing with capillary blood:
Lancing device approved for professional use
(e.g., the AccuChek Safe-T-Pro Plus lancing device or the CoaguChek Lancets) If you use capillaries, do not use glass capillary tubes or capillary tubes that contain anticoagulants. Cotton ball and alcohol wipe u What can the system do for you? (14) close the strip container immediately after removing a test strip. operate the meter at an ambient temperature between 12C and 32C (54F and 90F). For information on operating temperatures of test strips refer to the test strip package inserts. Test strip operating temperatures may differ from test parameter to test parameter. place the meter on a level, stable surface (table) or hold it so it is roughly horizontal. follow the information on correct handling of test strips in the package insert. CoaguChek ProII Operators Manual l 4 e p m a S d o o B a g n i t s e T 4 l 112 Never... l 4 e p m a S d o o B a g n i t s e T 4 l keep the test strip guide and housing clean. See also the chapter entitled Maintenance and Care starting with Cleaning and disinfecting the meter. Protection against infection:
r When collecting samples always observe the general precautions and guidelines relating to blood sampling. r Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice. u 8.2 Cleaning and disinfecting the meter (167) store the meter at high temperatures (above 35C or 95F) while it is in regular use. store the meter in damp or humid conditions without protection. remove or insert the code chip while the meter is performing a test. touch or remove the test strip during a test. wait more than 15seconds after a fingerstick before applying the blood. fingerstick a patient with wet hands (residues of water, sweat, or alcohol). add more blood after the test has begun. perform a test with a drop of blood from a previous puncture. CoaguChek ProII Operators Manual 113 CAUTION!
Accuracy/precision of measured results:
Failure to comply with the above may lead to inaccurate results. An incorrect result may lead to an error in diagnosis, therefore posing danger to the patient. Getting a good capillary blood sample Prepare the selected blood collection site and obtain blood from the patient per facility policy. If no facility policy exists for obtaining capillary blood, follow these recommendations:
Have the patient wash his or her hands in warm, soapy water. Or, clean the fingertip with an alcohol wipe. Make sure the fingertip and your gloved hands are thoroughly dry. Warm the hand. Have the patient hold it under his or her arm or use a hand warmer. Disinfect the blood collection site on the finger. Dry thoroughly. Have the patient let that arm hang down by his or her side before lancing a finger. Massage the finger from its base. Use these techniques until the fingertip has increased color. WARNING!
r Immediately after lancing, massage gently along the side of the finger to obtain a sufficiently large blood drop without pressing or squeezing too hard. r Apply the blood drop to the test strip immediately
(within 15seconds). CoaguChek ProII Operators Manual l 4 e p m a S d o o B a g n i t s e T 4 l 114 Getting a good result from venous whole blood l 4 e p m a S d o o B a g n i t s e T 4 l CAUTION!
Risk of false results caused by wet skin r When disinfecting the patients finger, allow it to dry thoroughly. Residues of disinfectant on the skin can dilute the drop of blood and so produce false results. For sample collection use a standard blood collection device. Do not use anticoagulants (e.g., EDTA, citrate, fluoride, oxalate, or heparin) to collect the blood sample. Venous blood samples may be collected from a venous line. If venous samples are collected by venipuncture, note the following:
Use a needle at least 23G (approx. 0.65mm) or larger in size. CAUTION!
r Discard the first four drops of blood collected
(within the first 10seconds). Then immediately apply one drop of blood (at least 8L) directly onto the target area of the test strip. Ensure that no air bubbles are introduced into the sample. Protection against infection:
r When collecting samples always observe the general precautions and guidelines relating to blood sampling. r Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice. CoaguChek ProII Operators Manual 4.2 Preparing to test 115 r To prepare to test 1 Have the test strip container at hand. 2 Make sure that the code chip supplied with these test strips is at hand. Each box of test strips contains a code chip. The parameter, the number on the code chip and the number on the test strip container must match. A capitalS in front of the number indicates that this code chip is for test strips. (A capitalC in front of the number indicates that it is a control solution code chip. See Chapter5, starting with Control testing). See 5.1 Control testing (133) Test strip code chip The code chip provides the meter with important information that it needs to perform the coagulation test. The chip contains information about the test method, the lot number, and the expiration date. The code chip is required, whenever a new test strip lot is used, so that the meter can read and store the lot information about that particular lot of test strips. The CoaguChek ProII meter stores the data from up to 60 test strip code chips that have been inserted. Do not forget to use the test strip code chip that is supplied with each pack of test strips before you perform the first test with these strips. We recommend that you leave the code chip in the meter to protect the electrical contacts in the meter from becoming dirty. CoaguChek ProII Operators Manual l 4 e p m a S d o o B a g n i t s e T 4 l 116 Each code chip belongs to a particular lot of test strips. Only remove the code chip when you are testing with test strips taken from a new pack. Protect the code chip from moisture and equipment that produces magnetic fields. r To insert the code chip 1 Remove the old code chip, if one is inserted in the meter. 2 Check that the number on the code chip matches the number on the label of the test strip container. l 4 e p m a S d o o B a g n i t s e T 4 l CoaguChek ProII Operators Manual 117 3 Slide the new code chip into the code chip slot (as shown) until you feel it snap into place. If the code chip is missing or incorrectly inserted, a corresponding error message appears in the display. See Chapter 9.1 Status / Error messages
(183) r To power on the meter 1 Place the meter on a level, vibrationfree surface, or hold it in your hand so it is roughly horizontal. 2 Power the meter on by pressing
. You can also power on the meter directly by inserting a test strip or connecting the power adapter. The next steps depend on whether you work with the function Operator ID set to inactive or active. See 7.1 Data handling (157) 3 If the function Operator ID is inactive, wait until the Main Menu is displayed. l 4 e p m a S d o o B a g n i t s e T 4 l CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetup 118 4 If the function Operator ID is active, without operator list, you are now prompted to enter an Operator ID.(4) Enter the Operator ID using the keypad. Touch to move to the next screen. 5 Alternatively, the Operator ID can also be entered using the builtin barcode scanner.(5),(6) Touch Scan and scan the operator barcode from a distance of approx. 1020cm (48inches), according to the barcode size. The meter beeps once the barcode has been read successfully. The barcode information appears in the operator ID field. The scanner turns off after 10 seconds, if a barcode is not scanned. 6 If the function Operator ID is active, with operator list, wait until the operator list is displayed. 7 Select the operator of choice by touching the corresponding button or touch Scan to scan an operator barcode. Note: Scanned operator IDs must also be on the list. Otherwise the login attempt will fail and an error message will be displayed. l 4 e p m a S d o o B a g n i t s e T 4 l
(4)
(5)
(6) For configuring operator and patient IDs, see (161) Configuring operator and patient IDs A list of supported barcode symbologies can be found in (202) A.2 Example of barcode symbologies A list of supported characters can be found in (206) A.3 Supported characters in 2D barcodes CoaguChek ProII Operators Manual 09:15 amOperator IDScan09:15 am05/29/2022OperatorScanAlan SmitheeJane BrownAnn CaseyJoe Dalton 119 8 Enter the (optional) password. 9 After you enter the password, touch to log on. The Main Menu is displayed and you can start the test. 10 When you touch displayed again.
, the operator pick list is 11 When the tests are completed or another operator wants to perform additional tests, touch Logout to log out (this button is available only when the Operator ID is activated). The meter returns to the display of the operator pick list. 12 Note: Extended data handling functionality and operator login options are dependent on the capabilities of the particular Data Management System (DMS) being used and may vary. For more details see 7.1 Data handling (157) l 4 e p m a S d o o B a g n i t s e T 4 l CoaguChek ProII Operators Manual Password09:15 amMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupLogout 120 4.3 Performing a test r To perform a test 1 Check the battery level. If the battery icon turns red (one bar remaining), there may not be enough power remaining for another test. If there are no bars remaining in the battery icon, you cannot perform any more tests. Power the meter off by pressing
. In both cases, restore power by recharging the battery pack, or using the power adapter. 2 Check that the date and time are correct. Correct any wrong entries as described in Chapter3, Meter Setup. To set the date (64) To set the time (65) 3 If a lockout (Operator or QC Lockout) is displayed instead of the Patient Test button, you must run a liquid quality control test before you can perform a patient test. See Chapter5, Control and Proficiency Testing, starting with 5.1 Control testing (133). When the meter is in lockout status, a patient test cannot be performed. The next steps depend on whether you work with or without patient lists. CoaguChek ProII Operators Manual l 4 e p m a S d o o B a g n i t s e T 4 l Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupMain Menu09:15 am05/29/2022Control TestReview ResultsSetupLogoutQC Lockout 121 4 If the Patient Test button is available, but a lockout is displayed (QC!), one or more test parameters are locked. A test can only be performed for parameters that are still unlocked or as a STAT test (if this function is enabled and if there are still STAT tests available). In these cases a QC status screen will be displayed after touching Patient Test. For more details see STAT Test Configuration (104) 5 With patient list go to step7. Without patient list, touch Patient Test. 6 If the Patient ID option was chosen as either Optional or Required when the meter was set up, you are prompted to enter a Patient ID. See Patient ID (90) If Required, enter the Patient ID, then touch to move to the next screen. If Optional, ignore the prompt and touch move to the next screen. The meter will assign the test a consecutive number. to If neither option was chosen, a screen appears that prompts you to insert a test strip. Continue with step11 or 12, depending on the meter setup. CoaguChek ProII Operators Manual l 4 e p m a S d o o B a g n i t s e T 4 l Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupLogout09:15 am05/29/2022TestQC statusLockedPatient IDScan09:15 am 122 7 With patient list, touch Patient Test. 8 Touch or to display the entry of choice. Select the patient to be tested from the list. 9 If the patient is not in the list, touch New to create a new entry. You must now enter a Patient ID using the keypad. Note: Extended data handling functionality and patient ID entry options are dependent on the capabilities of the particular Data Management System (DMS) being used and may vary. For more details see 7.1 Data handling (157) 10 Alternatively, the Patient ID can also be entered using the builtin barcode scanner.(7),(8) Touch Scan and scan the patient barcode from a distance of approx. 1020cm (48inches), according to the barcode size. f The meter beeps once the barcode has been read successfully.
(7)
(8) A list of supported barcode symbologies can be found in (202) A.2 Example of barcode symbologies A list of supported characters can be found in (206) A.3 Supported characters in 2D barcodes CoaguChek ProII Operators Manual l 4 e p m a S d o o B a g n i t s e T 4 l 09:15 am05/29/2022TestNewScanPatient IDScan09:15 am f The barcode information appears in the patient ID field. The scanner turns off after 10 seconds, if a barcode is not scanned. If the Parameter Selection option is enabled in the meter settings, you are now prompted to select the parameter to be tested. The testing procedure for both parameters is similar. For illustration purposes testing with PT test strips is shown as an example. 11 Touch the button to select the parameter you want to use. 12 The test strip icon prompts you to insert a test strip. Remove a test strip from its container and close the container again with the stopper. Exposure to external influences (such as humidity) may deteriorate the test strips and may lead to error messages. Therefore, always close the test strip container immediately after removing a test strip. 13 Hold the test strip so the lettering with the test name is facing upward. 14 Slide the test strip into the test strip guide in the direction indicated by the arrows. Slide the test strip in as far as it will go. A beep indicates that the meter has detected the test strip (provided the beeper is enabled). CoaguChek ProII Operators Manual 123 l 4 e p m a S d o o B a g n i t s e T 4 l 09:15 am05/29/2022aPTTPTTest09:15 am05/29/2022TestP-ID:Op:Par:PID01Smith, HenrySchulzPT 124 If you use a new test strip lot and have not inserted the code chip yet, you must do so now. Otherwise you cannot perform a test. The meter displays the number of the code chip belonging to the new test strip lot. Depending on the setting, you may also be required to run a liquid quality control test at this point. The hourglass icon shows that the test strip is warming up. When the warmingup process is complete, a further beep (provided the beeper is enabled) indicates that you can now apply blood. The blood drop icon flashes to indicate that the meter is ready to perform the test and is waiting for blood to be applied. 15 A countdown begins. You must apply the drop of blood to the test strip before the countdown ends. Otherwise you will receive an error message. When the test is running, no operator action is required. The display dims to save energy. r To apply blood from the fingertip WARNING!
Use only a lancing device that is approved for use by healthcare professionals, such as the AccuChek Safe-T-Pro or SafeTPro Plus lancing devices, or the CoaguChek Lancets
(professionaluse lancets available only in the United States). Follow the manufacturers instructions. CoaguChek ProII Operators Manual l 4 e p m a S d o o B a g n i t s e T 4 l 09:15 am05/29/2022TestP-ID:Op:Par:PID01Smith, HenryOperator 1PT09:15 am05/29/2022TestP-ID:Op:Par:PID01Smith, HenryOperator 1PTCode:18409:15 am05/29/2022TestP-ID:Op:Par:PID01Smith, HenryOperator 1PTCode:1843:00Min. 1 Now lance the side of a fingertip with the lancing device. We recommend obtaining the capillary blood from the side of the fingertip as this causes the least pain. 2 CAUTION! Massage the lanced finger gently until a drop of blood is formed. Do not press or squeeze the finger. Apply the first drop of blood from the finger. Apply the blood directly from the finger to the semicircular, transparent sample application area on top of the test strip. Alternatively you can touch the blood drop against the side of the sample application area. The test strip draws up the blood by capillary action. During this process you must hold the blood drop to the test strip until the flashing blood drop icon is no longer displayed and the meter beeps (provided the beeper is enabled). Apply the blood drop to the test strip within 15seconds of lancing the fingertip. Applying blood after this period of time may lead to an erroneous result (as the coagulation process would already have started). When applied from above, the blood must cover the entire sample application area. r To apply blood with a syringe 1 CAUTION! Discard the first four drops of blood collected (within the first 10seconds). CoaguChek ProII Operators Manual 125 l 4 e p m a S d o o B a g n i t s e T 4 l 126 2 Immediately apply one drop of blood (at least 8L, but not more than 20L) directly onto the target area of the test strip. Ensure that no air bubbles are introduced into the sample. If too much blood has been applied (>20 L) the exterior of the meter and the test strip guide should be cleaned and disinfected. For additional information on sample collection see Getting a good result from venous whole blood
(114) You hear a beep tone when you have applied enough blood (provided the Beeper is enabled). The blood drop symbol disappears and the test starts. Do not add more blood sample. To avoid error messages do not touch the test strip until the result is displayed. The meter performs an automatic quality control test on the test strip before it displays the test result. QC appears in the display. Following a successful outcome of the quality control test, a checkmark appears after QC. The result is displayed in the unit you chose when setting up the meter. It is automatically saved. For information on the valid measuring ranges for CoaguChek test strips refer to the package insert of the respective test strip. CoaguChek ProII Operators Manual l 4 e p m a S d o o B a g n i t s e T 4 l 09:15 am05/29/2022TestP-ID:Op:Par:PID01Smith, HenryOperator 1PTCode:18409:15 am05/29/2022TestP-ID:Op:Par:PID01Smith, HenryOperator 1PTCode:184QC09:15 am05/29/2022TestP-ID:Op:Par:PID01Smith, HenryOperator 1PTCode:18411/14/2021 07:30 amINR%Q2.521Doctor NotifiedSickTravel09:15 am05/29/2022TestP-ID:Op:Par:PID01Smith, HenryOperator 1PTCode:18411/14/2021 07:30 amINR>8.0 127 3 Results that are above or below the measuring range are indicated by the symbols > (above) or <
(below). If a C is displayed along with the result:
This may occur if the hematocrit value is very low or due to erroneous blood collection (e.g., wet hands). Repeat the test. If using capillary blood, make sure that the patient's hands are dry. If the message persists, perform a hematocrit check. If a is displayed along with the result:
This may occur if the test result is out of normal range. Touch the Normal Range information screen. icon to display the Out Of When interpreting results, refer to the detailed information on limitations and interferences included in the limitations section of the test strip package insert. r To accept/reject a test result 1 If this function is enabled, you may choose to accept or reject a test result. When the result is displayed, touch Reject or Accept CoaguChek ProII Operators Manual l 4 e p m a S d o o B a g n i t s e T 4 l TestP-ID:Op:Par:Code:PID05Mller, DavidSchulzPT20803/12/2022 08:00 am1.6INR1.6INR09:15 am05/29/202209:15 am05/29/2022TestP-ID:Op:Par:PID01Smith, HenryOperator 1PTCode:18411/14/2021 07:30 amINR1.6Measurement Result OK?RejectAcceptComment RequiredA comment is required if youreject a result. Please enter acomment.09:15 am05/29/2022TestP-ID:Op:Par:PID01Smith, HenryOperator 1PTCode:18411/14/2021 07:30 amRejectedWill Repeat Test 128 2 If you reject a result, you must enter a comment with an explanation. If you reject the result, this test result is no longer displayed. However, the test entry is stored. If a C is displayed along with the result:
This may occur if the hematocrit value is very low or due to erroneous blood collection (e.g., wet hands). Repeat the test. If using capillary blood, make sure that the patient's hands are dry. If the message persists, perform a hematocrit check. If a is displayed along with the result:
The range settings can only be set and enabled using a DMS. r To add comments You can add up to three comments to a test result. Comments can provide, for example, additional information about the test conditions or the patient. A comment may be up to 20characters in length. You can open the function for adding comments directly in the results screen. 1 To add comments:
In the Test screen, touch
. If you want to add a comment, do not remove the test strip. Once the strip is removed, the meter automatically returns to Main Menu and a comment can no longer be added. CoaguChek ProII Operators Manual l 4 e p m a S d o o B a g n i t s e T 4 l 09:15 am05/29/2022TestP-ID:Op:Par:PID01Smith, HenryOperator 1PTCode:18411/14/2021 07:30 amINR%Q2.521 2 Select the desired predefined comment(s) from the display list (if configured) or 3 Touch Custom to enter your own custom comment. Use the keypad (as with login) to enter your comment. 4 Once you have selected the desired comment(s), touch to return to the results screen. The printer icon only appears if the printer function is activated. Otherwise it is not displayed. Test results are also saved when the meter is powered off in the results screen or automatically powers off. r To display the test results as a QR code The QR code icon only appears if the QR code display function is activated. Otherwise it is not displayed. See To enable/disable the QR Code display (73) 1 Touch to display the result as QR code. 2 Touch to return to the standard result display. The size of the QR code displayed on the screen varies according to the amount of data encoded. r To finish the test CAUTION! Protection against infection: When collecting samples always observe the general precautions and guidelines relating to blood CoaguChek ProII Operators Manual 129 l 4 e p m a S d o o B a g n i t s e T 4 l AsymptomaticCleaned MeterDoctor NotifiedSickCustomComment09:15 am05/29/202209:15 am05/29/2022TestP-ID:Op:Par:PID01Smith, HenryOperator 1PTCode:18411/14/2021 07:30 amINR%Q2.521Doctor NotifiedSickTravel09:15 am05/29/2022P-ID:Op:Par:Code:OperatorPT03/12/2022 08:00 amINR2.521%QDoctor NotifiedSickNEW MEDICATIONTestPID01Smith, Henry09:15 am05/29/2022Test 130 sampling. Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice. 1 After the test result is displayed, touch will be prompted to remove the strip. You 2 Remove the test strip from the meter. Safety information (19) 3 Power the meter off. 4 Clean the meter if necessary. See Chapter8, Maintenance and Care starting with r To perform a STAT test STAT tests are a limited number of tests that can be performed in emergency situations. If the meter is configured to perform STAT tests, you have the option of performing a test by choosing STAT even though a QC Lockout is in place. See STAT Test Configuration (104) l 4 e p m a S d o o B a g n i t s e T 4 l 1 To perform the measurement without performing a quality control test, touch Patient Test. 2 Touch the button to select the parameter you want to use. CoaguChek ProII Operators Manual Remove09:15 am05/29/2022Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupLogout09:15 am05/29/2022TestQC statusLocked09:15 am05/29/2022aPTTPTTestSTAT Info%ld STAT tests remainingbefore lockout. 131 3 Touch tests. to confirm the number of remaining STAT 4 Perform the test. When a STAT test is performed, this information is stored with the result. The number of STAT tests allowed is reduced by 1. After all pending quality control tests are performed, the specified number of STAT tests is available again in case of a new lockout. The default setting is three for the number of STAT tests allowed when in QC Lockout. l 4 e p m a S d o o B a g n i t s e T 4 l CoaguChek ProII Operators Manual 09:15 am05/29/2022TestP-ID:Op:Par:PID01Smith, HenryOperator 1PTCode:18411/14/2021 07:30 amINR%Q2.521STAT Test 132 Page intentionally left blank. CoaguChek ProII Operators Manual 5 Control and Proficiency Testing 5.1 Control testing 133 The CoaguChek ProII meter has a number of builtin quality control functions:
A check of the electronic components and functions every time the meter is powered on. A check of the test strip temperature while a test is in progress. A check of the expiration date and lot information on the test strip carried out by the code chip. An onboard quality control within every single test strip. Roche Diagnostics offers liquid quality controls for the CoaguChek ProII system. These controls are designed to assist you in meeting regulatory compliance requirements at your facility. To perform an optional liquid quality control test using control solutions, you need:
CoaguChek ProII meter. The test strip code chip supplied with the test strip container you are using (a code chip is provided with every test strip pack). Test strips that came with the code chip mentioned above. Bottles of CoaguChekPT Controls, CoaguChekaPTT Controls, diluent droppers, and the quality control code chip provided. You can choose the frequency of liquid quality control tests in the meter setup (see Chapter 3, Meter Setup, QC (quality control) Lockout). If the control results in the display are in the specified range, this confirms that the liquid control test was performed correctly. 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 CoaguChek ProII Operators Manual 134 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 5.2 Preparing to perform a liquid quality control test Prepare for a liquid quality control test in the same way you would prepare to perform a test with a capillary blood sample. The only difference is the use of control solution instead of blood. r To prepare for a liquid quality control test 1 Have the test strip container at hand. 2 If you are using the test strip lot for the first time, make sure that the code chip that came with these test strips is at hand. 3 Make sure the bottle of freezedried (lyophilized) control plasma and the dropper for making the control solution are at hand. Always refer to package inserts for information on the specified operating conditions. CoaguChek ProII Operators Manual 4 Make sure that the quality control code chip that came with the control solution is at hand. 5 Open the lid of the bottle and remove the rubber cap. 6 Hold the dropper with the sealed dropper neck pointing upward, then cut off the end of the seal with scissors. Do not hold the dropper close to your face. To avoid loss of diluent, hold the dropper by the stem;
do not squeeze the bulb of the dropper while cutting the tip. 135 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 CoaguChek ProII Operators Manual 136 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 7 Apply gentle pressure to the reservoir to transfer the entire contents of the dropper to the bottle. Make sure that the dropper does not come into contact with the dried control plasma. 8 Close the bottle again. 9 Make sure the dropper is at hand for the next steps in the liquid quality control test. 10 Swirl the bottle using a circular motion to completely dissolve all of the control plasma inside. Do not shake the bottle or turn it on its side. Doing so can cause components in the control plasma to stick to the sides of the bottle. Please refer to the control solution package insert. The control solution is now ready to be applied to the test strip. For further information refer to the respective package insert(s). CoaguChek ProII Operators Manual 5.3 Performing a liquid quality control test r To perform a liquid quality control test 1 Place the meter on a level, vibrationfree surface or hold it in your hand so it is roughly horizontal. 2 Power the meter on by pressing
. You can also power on the meter directly by inserting a test strip or connecting the power adapter. 3 Wait until the Main Menu is displayed, or log on as described in To power on the meter (117) 4 Check the battery level. If the battery icon turns red (one bar remaining), there may not be enough power remaining for another test. If there are no bars remaining in the battery icon, you cannot perform any more tests. Power the meter off by pressing
. In both cases, restore power by recharging the battery pack, or using the power adapter. 5 Check that the date and time are correct. Correct any wrong entries as described in Chapter 3, Meter Setup. To set the date (64) To set the time (65) CoaguChek ProII Operators Manual 137 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetup 138 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 6 Touch Control Test. 7 In the QC Test menu, touch Control Test again. 8 Touch the button to select the parameter you want to use. 9 The test strip icon prompts you to insert a test strip. Remove a test strip from its container and close the container again with the stopper. Exposure to external influences (such as humidity) may deteriorate the test strips and may lead to error messages. Therefore, always close the test strip container immediately after removing a test strip. 10 Hold the test strip so the lettering with the test name is facing upward. 11 Insert the test strip into the test strip guide in the direction indicated by the arrows. Slide the test strip in as far as it will go. A beep indicates that the meter has detected the test strip (provided the beeper is enabled). CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetup09:15 am05/29/2022QC TestPar:Op:PTSchulz09:15 am05/29/2022aPTTPTQC Test09:15 amQC Test05/29/2022Control TestProficiency Test 12 If you are using a new test strip lot and have not inserted the test strip code chip yet, you must do so now. Otherwise you cannot perform a quality control test. As with the test strips, a quality control code chip is also provided with the control solutions. This chip informs the meter about the acceptable ranges of results for that lot of controls. The information on the code chip is retained in the memory so you can use the same control solutions at any time. 13 Select the code stored for your current control solution or touch New Code to use a new control solution. When entering or selecting a code manually, make sure it matches the code printed on the bottle of the control solution. 14 Alternatively, the control solution code can also be entered using the builtin barcode scanner. Touch Scan and scan the barcode on the label from a distance of approx. 10cm (4inches). The meter beeps once the barcode has been read successfully. The barcode information appears in the code field. The scanner turns off after 10seconds, if a barcode is not scanned. 15 If you are using a new control solution, remove the strip code chip from the meter and insert the code chip that came with the control solution instead. 139 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 CoaguChek ProII Operators Manual Op:Operator 11.6INR18409:15 am05/29/2022QC TestQC TestNew CodeQC 070QC 060QC 050QC 048Scan09:15 am05/29/2022Op:Par:Code:184PT1.6INR09:15 am05/29/2022Operator 1QC Test 140 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 If the code chips get mixed up, check the letter on the code chips to tell them apart. A capital S in front of the number indicates that this code chip is for test strips. A capital C in front of the number indicates that it is a control solution code chip. 16 If performing more than one level, select the level for this measurement. The hourglass icon shows that the test strip is warming up. When the warmingup process is complete, a further beep (provided the beeper is enabled) indicates that you can now apply the control solution. The dropper icon flashes to indicate that the meter is ready to perform the test and is waiting for the sample to be applied. At the same time a countdown begins. You must apply the sample within the displayed time, otherwise you will receive an error message. CoaguChek ProII Operators Manual Op:Par:Code:184PT09:15 am05/29/2022Operator 1QC Test999QC:LevelLevel12Op:Par:Code:184PT09:15 am05/29/2022Operator 1QC Test999QC:Level:1Op:Par:Code:184PT09:15 am05/29/2022Operator 1QC Test999QC:Level:13:00Min. 141 17 Using the dropper, draw up the dissolved contents of the bottle. 18 Apply a single drop of control solution directly from the dropper to the semicircular, transparent sample application area on top of the test strip. Do not add more control solution. You hear a beep when you have applied enough control solution (provided the beeper is enabled). The dropper icon disappears and the test starts. The result of the liquid quality control test is displayed. It is automatically saved to memory. The acceptable range of results for the liquid control is displayed below the current result, along with Pass or Fail. The unit that is not the leading unit, is shown in gray. The range used for this unit is the manufacturer-
specified range. If the custom range has been manually defined, then this is the one that is used only for the PT leading unit. 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 CoaguChek ProII Operators Manual Op:Par:Code:184PT09:15 am05/29/2022Operator 1QC Test999QC:Level:1Op:Par:Code:184PT09:15 am05/29/2022Operator 1QC Test999QC:Level:102/10/2022 08:30 amINRPass:(1.0 - 1.4 INR)78 %Q(53 - 99 %Q)1.2 142 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 Note: The arrow (next to the result) refers to the INR result only. If you have selected to display INR and %Quick or INR and seconds, the (up or down) arrow next to the result refers only to the INR value. Regardless of the Result Units PT settings, aPTT is always displayed in seconds. See To configure an additional parameter (59) The printer icon only appears if the printer function is activated. Otherwise it is not displayed. 19 If you want to add a comment, touch
. 20 Select the desired predefined comment(s) from the pick list (if configured) or 21 Touch Custom to enter your own custom comment. Use the keypad (as with login) to enter your comment. A comment may be up to 20characters in length. 22 Once you have selected the desired comment(s), touch to return to the results screen. After the test result is displayed, touch will be prompted to remove the strip. You 23 Remove the test strip from the meter. If you are performing a 2level control and the 2LevelQC function is enabled, you will now be asked to insert a new strip to proceed with the second level. Otherwise the meter returns to the Main Menu. 24 Power the meter off. 25 Remove the quality control code chip from the meter and store it with the controls. CoaguChek ProII Operators Manual Op:Par:Code:184PT09:15 am05/29/2022Operator 1QC Test999QC:Level:102/10/2022 08:30 amINRFail:(1.0 - 1.4 INR)110%Q(53 - 99 %Q)0.9QC Comment09:15 am05/29/2022Acceptable Cntrl.Cleaned MeterDoctor NotifiedNew Control LotCustomRemove09:15 am05/29/2022 26 Clean the meter if necessary (see Chapter 8, Maintenance and Care starting with 27 CAUTION! Dispose of controls and used test strips from control testing in accordance with the disposal policy of your facility. The control solution contains animal material, which should be considered as potentially infectious. 143 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 CoaguChek ProII Operators Manual 144 5.4 Proficiency testing Observe the applicable regulations and directives of the responsible regulatory agencies when performing proficiency tests. Proficiency tests are performed on samples whose values are unknown to the operator performing the test. These samples are provided by an external source, and the results should be forwarded to the appropriate source after completing the test. The samples supplied are treated in the same manner as regular patient samples. Proficiency testing provides another means of verifying that your technique, reagents, system, and testing performance are as they should be. Some regulatory agencies require that these proficiency samples be tested as part of an institution's quality assurance program before an institution can be certified. When using a data management system for configuration, it is possible to partially or fully disable the functions described in this chapter. In this case, the corresponding selection screen does not appear
(after you touch Control Test). 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 CoaguChek ProII Operators Manual 5.5 Preparing to perform a proficiency test You prepare for a proficiency test in the same way you would prepare to perform a test with a capillary blood sample. The only difference is the use of the proficiency sample supplied instead of blood from a patient. To perform a proficiency test you need the following:
The information of at least one code chip for test strips must be stored in the meter and must match the lot number of the test strips used. The correct test strips must be available. The proficiency sample must be available. If you are using the test strip lot for the first time, make sure that the code chip supplied with these test strips is at hand. CoaguChek ProII Operators Manual 145 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 146 5.6 Performing a proficiency test r To perform a proficiency test 1 Place the meter on a level, vibrationfree surface or hold it in your hand so it is roughly horizontal. 2 Power the meter on by pressing
. You can also power the meter on directly by inserting a test strip or connecting the power adapter. 3 Wait until the Main Menu is displayed, or log on as described in To power on the meter (117) 4 Check the battery level. If the battery icon turns red (one bar remaining), there may not be enough power remaining for another test. If there are no bars remaining in the battery icon, you cannot perform any more tests. Power the meter off by pressing
. In both cases, restore power by recharging the battery pack, or using the power adapter. 5 Check that the date and time are correct. Correct any wrong entries as described in Chapter3, Meter Setup. To set the time (65) To set the date (64) 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 CoaguChek ProII Operators Manual Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetup 147 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 6 Touch Control Test. 7 Touch Proficiency Test. For proficiency testing, the test parameter information is read from the test strip. 8 The test strip icon prompts you to insert a test strip. Remove a test strip from its container and close the container again with the stopper. Exposure to external influences (such as humidity) may deteriorate the test strips and may lead to error messages. Therefore, always close the test strip container immediately after removing a test strip. 9 Hold the test strip so the lettering with the test name is facing upward. 10 Slide the test strip into the test strip guide in the direction indicated by the arrows. Slide the test strip in as far as it will go. A beep indicates that the meter has detected the test strip (provided the beeper is enabled). CoaguChek ProII Operators Manual 09:15 am05/29/2022ProficiencyMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetup09:15 amQC Test05/29/2022Control TestProficiency Test 148 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 11 Enter or scan the sample ID. The hourglass icon shows that the test strip is warming up. When the warmingup process is complete, a further beep (provided the beeper is enabled) indicates that you can now apply the proficiency sample. The dropper icon flashes to indicate that the meter is ready to perform the test and is waiting for the sample to be applied. A countdown begins at the same time. You must apply the sample within the displayed time or an error message will be displayed. 12 Apply a single drop of the sample directly from the dropper to the semicircular, transparent sample application area on top of the test strip. Do not add more of the sample. CoaguChek ProII Operators Manual Proficiency09:15 am05/29/2022QC:Code:Par:Min.3:00Proficiency09:15 am05/29/2022QC:Code:Par:Sample ID09:15 amScan You hear a beep when you have applied enough of the sample (provided the beeper is enabled). The dropper icon disappears and the test starts. 13 The result of the proficiency test is displayed, the comment Proficiency is automatically added. If you want to add further comments, touch
. The test result is automatically saved to memory. After the test result is displayed, touch will be prompted to remove the strip. You 14 CAUTION! Dispose of used test strips from proficiency testing in accordance with the disposal policy of your facility. Remove the test strip from the meter. 15 Power the meter off. 16 Clean the meter if this becomes necessary (see Chapter8, Maintenance and Care, starting with 149 5 g n i t s e T y c n e c i f o r P d n a i l o r t n o C 5 CoaguChek ProII Operators Manual Proficiency09:15 am05/29/2022QC:Code:Par:Proficiency09:15 am05/29/2022QC:Code:Par:Proficiency03/12/2022 08:00 am 150 Page intentionally left blank. CoaguChek ProII Operators Manual 6 Review Results (Memory) The CoaguChek ProII meter can save 2000patient test results as well as 500liquid quality control tests to memory, together with respective time and date. In addition, up to 120code chip records (contents of 60 test strip code chips and 60control solution code chips) are stored. If you are using operator and/or patient lists, a maximum of 5000Operator and 4000Patient IDs is allowed. If the memory is full when you perform a test, the oldest result is automatically deleted. The most recent result is always saved. This applies both to patient results and to quality control tests. In order to avoid the loss of stored test results, you can archive this data using a data management system and the optional Handheld Base Unit. u 7.1 Data handling (157) 151 6
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s t l u s e R w e v e R 6 i CoaguChek ProII Operators Manual 152 6.1 Viewing test results r To view test results 1 Place the meter on a level, vibrationfree surface, or hold it in your hand so it is roughly horizontal. 2 Power the meter on by pressing
. 3 Wait until the main menu is displayed. 4 Touch Review Results 5 Select the type of results you want to view. Display Patient Result memory Display QC Result memory. 6 Select the test parameter(s) you want to view. For displaying patient results:
Parameter selection is only available, if the sort order has been set to Date/Time See To set the sorting order of lists (68) CoaguChek ProII Operators Manual 6
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s t l u s e R w e v e R 6 i Main Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupMemoryPatient ResultQC Result09:15 am05/29/2022Memory09:15 am05/29/2022All resultsaPTTPT 153 If the sort order has been set to Patient ID or Patient Name, the patient result screen is shown directly. r Buttons used for displaying results The following buttons for general use are located in the views described below:
Menu icon: Return to main menu. Return icon: From the singleresult display, return to the list of results. Individual icon: List that contains entries for this patient only. Printer icon: The printer icon only appears if the printer function is activated. Otherwise it is not displayed. QR Code icon: The QR code icon only appears if the QR code display is activated. Otherwise it is not displayed. r To display the patient result memory This memory area contains all patient test results. They are sorted according to the order you defined for the option Sort. If the Sort option is set to Date/
Time they are filtered by means of the test parameter you previously selected, the most recent results are at the top of the list. See To set the sorting order of lists (68) 6
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s t l u s e R w e v e R 6 i CoaguChek ProII Operators Manual Memory09:15 am05/29/202203/12/2022 08:00 am02/10/2022 08:30 am11/14/2021 07:30 am10/10/2021 07:05 am01/02/2022 10:17 amMemoryP-ID:Op:Par:Code:05/29/202203/12/2022 08:00 amDoctor NotifiedSickNew Strip Lot09:15 amP-ID:Memory03/12/2022 08:00 am02/10/2022 08:30 am11/14/2021 07:30 am05/29/202209:15 am 1 Touch or to scroll to the entry of choice on the screen. 2 Touch the entry you want to open. The entry is displayed. 3 Touch
. The results for the selected patient are displayed. If you choose to display patientrelated lists, you cannot filter a list by test parameters. QR code icon only appears if the QR code The display function is activated. Otherwise it is not displayed. 4 Touch to display the result as QR code. 5 Touch to return to the standard result display. 154 6
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s t l u s e R w e v e R 6 i CoaguChek ProII Operators Manual MemoryP-ID:Op:Par:Code:05/29/202203/12/2022 08:00 amDoctor NotifiedSickNew Strip Lot09:15 am09:15 am05/29/2022Memory r To display the QC (quality control) result memory This memory area contains all liquid quality control tests that were run, sorted chronologically. The most recent results are at the top of the list. 1 Touch or to scroll to the entry of choice on the screen. 2 Touch the entry you want to open. The entry is displayed. 155 6
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s t l u s e R w e v e R 6 i CoaguChek ProII Operators Manual QC03/12/2022 08:00 am02/10/2022 08:30 am11/14/2021 07:30 am01/02/2022 10:17 am10/10/2021 07:05 amQC 999 PassQC 234 PassQC 623 PassQC 333 PassQC 432 Pass09:15 am05/29/2022Op:Par:Code:184PT09:15 am05/29/2022Operator 1QC Test999QC:Level:102/10/2022 08:30 amINRPass:(1.0 - 1.4 INR)78 %Q(53 - 99 %Q)1.2New Control LotNew Strip Lot 156 Page intentionally left blank. CoaguChek ProII Operators Manual 7 Extended Functionalities 7.1 Data handling Note: Extended data handling functionality is dependent on the capabilities of the particular Data Management System (DMS) being used and may vary. When used in conjunction with the Handheld Base Unit from Roche Diagnostics (available separately), the CoaguChek ProII meter can conveniently connect to a data management system (DMS). The main advantages of such a connection between meter and DMS may include:
Transferring patient lists, operator lists, and settings from the DMS to the meter. In this way the setup for daily work as well as general meter setup can be performed (for one or more meters) quickly and conveniently. Transferring all stored test results with the corresponding PatientID, OperatorID, and comments from the meter to the DMS. This transfer of data permits further evaluation or proper archiving according to your needs. Through the DMS the system administrator (such as the POC coordinator) may specify what settings are to be applied to a set of meters within a site or unit (e.g., hospitals or wards). All meters assigned to a specific site and/ or unit would consequently share the same settings. The different operator and patient lists (that match a site or unit) are then made available on their respective meters. Other settings such as QCLockout and OperatorLockout may easily be set (once) and distributed to all meters. CoaguChek ProII Operators Manual 157 7 s e i t i l a n o i t c n u F d e d n e t x E 7 158 Computer (Setup option) Operator lists 7 s e i t i l a n o i t c n u F d e d n e t x E 7 The option of setting up an Operator Lockout is available only when operator lists are created on the DMS, stored in the meter, and Operator login is activated. See Operator login (in Operator ID) and Operator Lockout for more details. u Operator ID (89) u Operator Lockout (100) For initial connection to a DMS, the ability to communicate within a network has to be set up as follows:
In the Setup Menu, the Connection option must be set to Computer. The Handheld Base Unit must be configured correctly. (For details please refer to the manual of the Handheld Base Unit and the Technical Note stored on the Handheld Base Unit itself.) Place the meter on a Handheld Base Unit that is connected to the network. The meter will automatically be recognized by the DMS and may now be assigned to a site and/or unit managed by the DMS (if your DMS has that functionality). Depending on DMS functionality available, the DMS may transfer settings and lists to the meter as well as enable test results to be transferred from the meter to the DMS. u To open the connection menu (72) After powering the meter on, an Operator login may be configured. There are four possible configurations for an Operator login:
Operator is activated, but there is no list available:
The Operator can either log in via the onscreen keypad or a barcode scan. The use of the meter is not restricted to a predefined Operator group, so CoaguChek ProII Operators Manual OperatorIDs are entered via the onscreen keypad or read from the barcode and stored with test results for informational purposes only. This first configuration is also available without a DMS. Operator is activated, there is no list available and the List feature is set to hidden (only possible with a DMS). Setting the "List" feature to "hidden"
with the DMS automatically blocks the display of the meter's onscreen keypad as well. The Operator can only log in via a barcode scan as there is no onscreen keypad. The use of the meter is not restricted to a predefined Operator group, so Operator IDs are read from the barcode and stored with test results for informational purposes only. Meters which are managed by a DMS may receive an Operator list. Operator is activated, a list is available and displayed on the login screen:
The Operator selects the ID from the displayed list. If so configured by the Administrator, the Operator may also be required to enter a password to log in. Operator is activated, a list is available but set to hidden:
The Operator can login via a barcode scan. If so configured by the Administrator, the Operator may also be required to enter a password to log in. When working with operator lists: The use of the meter is restricted to the operators on this list. When starting a Patient Test, there will be the option of either selecting a PatientID from a patient list, entering the PatientID using the onscreen keypad or, if available, of scanning the barcode with the PatientID. The Patient ID, if entered on the DMS, comes with an additional 159 7 s e i t i l a n o i t c n u F d e d n e t x E 7 Patient lists CoaguChek ProII Operators Manual 160 7 s e i t i l a n o i t c n u F d e d n e t x E 7 identification entry. Up to 20characters can be used and assigned as a second confirmation (e.g., name, date of birth). There are four possible configurations for a PatientID input:
The PatientID is set to Optional or Required, and there is no list available:
A PatientID can be entered manually via the onscreen keypad or read in via a barcode scan. The PatientID is stored with the test result. The PatientID is set to No, but there is a list available: The list of PatientIDs is always shown when starting a test. You may now:
select a patient from the list;
scan a PatientID using the barcode scanner;
create a new patient entry by touching New. Instead of an ID a consecutive number will be assigned to this result. The PatientID is set to Optional or Required, and there is a list available: The list of PatientIDs is always shown when starting a measurement. You may now:
select a patient from the list;
scan a PatientID using the barcode scanner;
create a new patient entry by touching New. You may either read the ID using the barcode scanner or enter a new ID via the onscreen keypad. The PatientID is set to hidden (only possible with a data management system), and there is a list available: When you start the test, the screen is blank and Scan is displayed. CoaguChek ProII Operators Manual 161 You may now scan a PatientID using the barcode scanner. If the patientID is on the list, the test will proceed. If the patientID is not on the list, you will get an error message. Note that the scanned Patient ID must already be on the list that is sent from the DMS to the meter. You cannot use the scanner to scan and enter a new Patient ID if the Patient ID is set to hidden. Depending on DMS settings, you have the following options for patient list validation when working with Patient lists:
A PatientID does not have to be on the list to be used (only valid for validation mode off). The meter displays a warning if the PatientID entered is not on the list. The meter displays an error message if the ID was not found on the list of valid PatientIDs. To proceed with the test, you must scan (if ID set to hidden) or select (if ID set to Required) a valid PatientID. When creating operator and patientIDs, apply the following rules:
PatientIDs can consist of up to 20alphanumeric characters, with specified minimum and maximum lengths. OperatorIDs can consist of up to 20alphanumeric characters. Alphanumeric characters are any combination of AZ and 09, additionally . (period), or (hyphen) may be used. 7 s e i t i l a n o i t c n u F d e d n e t x E 7 Patient list validation Configuring operator and patient IDs CoaguChek ProII Operators Manual 162 Barcode scanner Stored test results and comments 7 s e i t i l a n o i t c n u F d e d n e t x E 7 Using a DMS, the barcode scanner may be configured to accept only selected barcode symbologies. A list of supported barcode symbologies can be found in Appendix A2 and a list of supported characters in Appendix A.3. Barcode masking can be used to eliminate any characters not belonging to the Operator ID. For more information, see Operator and patient ID barcode masks. u A.1 Operator and patient ID barcode masks (201) u A.2 Example of barcode symbologies (202) u A.3 Supported characters in 2D barcodes (206) When performing a test, the test result will be stored along with additional information, including the PatientID, OperatorID, the kind of test performed, and optional Comments. The meter comes with a default set of Comments that can be assigned to each test result. If you are working with a DMS, these comments can be replaced by the comments in the DMS. The new wording will then be available for selection from the Comments list in the meter. Up to 3 comments can be assigned to each result. The default preset comments in the meter are:
Patient result comments QC results comment Asymptomatic Acceptable Control Cleaned Meter Cleaned Meter Doctor Notified Doctor Notified Sick Travel New Control Lot New Lot Number CoaguChek ProII Operators Manual Patient result comments QC results comment Lab Draw No Action New Strip Lot New Strip/Kit Lot Procedure Error No Action Under Medication Procedure Error Will Repeat Test Proficiency Test Changed Dosing Repeat Control Test RN Notified Switched QC Vial Will Repeat Test For more information and technical details, please refer to the manual of the Handheld Base Unit and the Technical Note stored on the Handheld Base Unit itself. 163 7 s e i t i l a n o i t c n u F d e d n e t x E 7 CoaguChek ProII Operators Manual 164 Page intentionally left blank. CoaguChek ProII Operators Manual 8 Maintenance and Care 8.1 Conditions for storage and shipping Storage Store the system and test strips in the same environment in which they are used. Do not store the meter in direct sunlight or under extreme temperature conditions. Observe the limits for temperature and humidity when storing and using the meter (see Chapter10). u 10.1 Technical data (193) CoaguChek ProII Operators Manual 165 8 e r a C d n a e c n a n e t n a M 8 i 166 Shipping 8 e r a C d n a e c n a n e t n a M 8 i r Observe the following safety information when shipping the meter and battery pack. Failure to do so may result in injury to persons or damage to the meter or battery pack. If the meter is shipped or transported over long distances, always remove the battery pack from the meter. This eliminates the possibility of the battery pack overheating due to a shortcircuit in the meter. It also prevents deep discharge and other damage to the battery pack or meter. Only ship undamaged battery packs. Damaged battery packs must be disposed of locally. See Battery pack for the risks associated with damaged battery packs and disposal information. Package the battery pack for shipping so that it cannot move around in the packaging. Also observe any other applicable national regulations. When shipping via third parties (e.g., by air or parcel service), work with the carrier to check whether specific requirements need to be met in relation to the lithiumion battery packs on the basis of national or international laws on hazardous goods and, where applicable, if special packaging and labeling requirements apply. u Battery pack (22) For short distances example between a facilitys sites users may transport the battery packs (either installed in the meter or separately) by road without having to meet further requirements. CoaguChek ProII Operators Manual 8.2 Cleaning and disinfecting the meter 167 r Observe the disinfection guidelines of your institution. r Protective gloves should always be worn when cleaning and disinfecting the device. NOTICE!
Follow the procedures below to clean/disinfect the meter. Failure to follow these procedures may cause malfunction of the meter. r Make sure the meter is powered off. r Do not spray anything onto the meter and do not immerse it in liquid. r Ensure that cloth or wipe is only damp, not wet. Remove excess moisture if necessary. Difference between cleaning and disinfecting Cleaning is the physical removal of organic soiling (e.g., dirt, or other foreign material) from the meter surface. When should the meter be cleaned and disinfected Disinfecting is the removal of most, but not all, diseasecausing and other types of microorganisms
(bloodborne pathogens) from the meter. The meter should be cleaned whenever visibly soiled. The exterior of the meter and the test strip guide should be cleaned and disinfected before being used on another patient. Maintenance cleaning: The use of the disinfecting cloths may lead to a buildup of residue on the test strip guide and battery compartment that needs to be removed. Frequency: whenever residue buildup is visible or at least once per month. 8 e r a C d n a e c n a n e t n a M 8 i CoaguChek ProII Operators Manual 168 8 e r a C d n a e c n a n e t n a M 8 i Follow recommendations from the FDA, CDC and CMC and your facilitys policies and procedures for infection control.(9),(10) The FDA recommends that Point of Care testing devices should be used on one patient only and not shared. If it is not possible for each individual patient to have a dedicated POC device, the meters must be properly cleaned and disinfected after every use or before being used on the next patient, following the guidelines given below.(11) Approved cleaning and disinfecting products The following active ingredients are tested and approved for cleaning and disinfecting the meter housing and test strip guide:
We recommend Super SaniCloth Germicidal Disposable Wipes (disposable wipes containing 0,5%
quaternary ammonium compounds [single compound or mixture] and up to 60% isopropyl alcohol [isopropanol]). This product contains the approved active ingredients and is licensed for use in Canada. The use of SaniCloth Plus Germicidal Disposable Wipes is not recommended.
(9) FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens; Initial Communication, (2010). http://www.fda.gov/
MedicalDevicesSafety/ AlertsandNotices/ucm224025.htm
(10) CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens, (2010). http://www.cdc.gov/injectionsafety/ FingerstickDevicesBGM.html
(11) Healthcare Infection Control Practices Advisory Committee (HICPAC), William A. Rutala, PhD., M.PH., and David J. Weber, M.D., M.PH. Centers for Disease Control and Prevention, 2008. Guideline for Disinfection and Sterilization in Healthcare Facilities. Atlanta, GA CoaguChek ProII Operators Manual NOTICE!
Damage to the instrument r Use only products containing the approved active ingredients. Do not use any other cleaning or disinfecting solutions as this could result in damage to the system components. For technical assistance or questions on cleaning and disinfecting, please contact Roche Care Center at 18772733433. 169 8 e r a C d n a e c n a n e t n a M 8 i CoaguChek ProII Operators Manual 170 8 e r a C d n a e c n a n e t n a M 8 i 8.3 Cleaning/disinfecting the exterior (meter housing) When to clean and disinfect the meter The exterior of the meter should be cleaned and disinfected before performing a test on a new patient. What to clean and disinfect The following parts of the meter may be cleaned/
disinfected:
The area around the test strip guide The meter display (touchscreen) The meter housing (entire meter surface front and back) The test strip guide and test strip guide cover If you notice any signs of deterioration after cleaning or disinfecting your meter, stop using it and contact Roche Care Center at 18772733433 for assistance. Ensure that the blue test strip guide cover remains tightly closed while cleaning or disinfecting the exterior housing. NOTICE!
r Do not allow liquid to enter the test strip guide or pooling of liquid on the touchscreen. If liquid does get into the test strip guide, immediately dry the components with a dry cloth. If solution is allowed to collect in any meter opening, severe damage to the system can occur. CoaguChek ProII Operators Manual 171 r To clean/disinfect the exterior 1 Clean the exterior. With the meter powered off, wipe the meters exterior clean with a fresh Super SaniCloth Germicidal Disposable Wipes. Remove any excess moisture from the the cloth before using it. Do not let liquid accumulate near any opening. Carefully wipe around the cover of the test strip guide and other openings. Ensure that no liquid enters the meter. Protective gloves should always be worn when cleaning and disinfecting the meter. 2 Dry the exterior After cleaning the housing, wipe away any residual moisture and fluids with a dry lintfree cloth. 3 Disinfect the exterior. Take a fresh Super SaniCloth Germicidal Disposable Wipes from the container. Remove excess moisture from the wipe. With the meter powered off, wipe the outside of the meter three times horizontally and three times vertically and carefully wipe around the test strip guide area. Do not let liquid accumulate near any opening. Carefully wipe around the cover of the test strip guide and other openings. Make sure that no liquid enters the meter. To properly disinfect, let the meter sit wet for a contact time of at least 2minutes, or as 8 e r a C d n a e c n a n e t n a M 8 i CoaguChek ProII Operators Manual 172 8 e r a C d n a e c n a n e t n a M 8 i instructed by the manufacturer in the product labeling. Always refer to the manufacturers labeling for contact time recommendations. 4 Dry the exterior. After the required contact time, dry the housing thoroughly with a dry lintfree cloth. Visually verify that no residual moisture is seen anywhere on the meter at the completion of cleaning and disinfecting. Ensure that the meter is completely dry before performing the next patient test. CoaguChek ProII Operators Manual 8.4 Cleaning/disinfecting the test strip guide When to clean and disinfect the test strip guide The test strip guide should be cleaned and disinfected whenever the housing is cleaned and disinfected (see above). NOTICE!
Damage to the instrument r Use only products containing the approved active ingredients. Do not use any other cleaning or disinfecting solutions as this could result in damage to the system components. u Approved cleaning and disinfecting products (168) r To clean/disinfect the test strip guide 1 Open the cover. With the meter powered off, use your thumbnail to open the cover of the test strip guide by pressing its front edge upward. Move the cover safely away from the meter. CoaguChek ProII Operators Manual 173 8 e r a C d n a e c n a n e t n a M 8 i 174 8 e r a C d n a e c n a n e t n a M 8 i 2 Clean the test strip guide cover. Clean the cover with a Super SaniCloth Germicidal Disposable Wipe. After cleaning, dry the test strip guide cover thoroughly with a dry lintfree cloth. 3 Clean the interior test strip guide Hold the meter upright with the test strip guide facing down. Clean the easily accessible area (shown in the illustration: white area and its black surrounding frame) with a Super SaniCloth Germicidal Disposable Wipe. Remove any excess moisture from the cloth. Do not clean beyond the white area inside the meter. After cleaning, carefully dry the test strip guide with a dry lintfree cloth. 4 Disinfect the test strip guide cover. Take a fresh Super SaniCloth Germicidal Disposable Wipe from the container. Remove excess moisture from the cloth. Disinfect the test strip guide cover by wiping with the germicidal cloth. To properly disinfect, let the test strip guide cover sit wet for a contact time of at least 2minutes, or as instructed by the manufacturer in the product labeling. Always refer to the manufacturers labeling for contact time recommendations. CoaguChek ProII Operators Manual 175 After the required contact time, carefully dry the test strip guide cover with a dry lintfree cloth. 5 NOTICE! Damage to the instrument Do not insert any objects into the test strip guide. Doing so could damage the electrical contacts behind the test strip guide. Disinfect the interior test strip guide. Hold the meter upright with the test strip guide facing down. Wipe the easily accessible area (shown in the illustration: white area and its black surrounding frame) with a fresh germicidal cloth. Do not clean beyond the white area inside the meter. Ensure the germicidal cloth is only damp, not wet. To properly disinfect, let the test strip guide sit wet for a contact time of at least 2minutes, or as instructed by the manufacturer in the product labeling. Always refer to the manufacturers labeling for contact time recommendations. 6 Dry the interior test strip guide. After the required contact time, carefully dry the test strip guide with a dry lintfree cloth. Let the inside of the test strip guide dry for at least 10 minutes before reattaching the test strip guide cover and testing again. Visually verify that no residual moisture is seen 8 e r a C d n a e c n a n e t n a M 8 i CoaguChek ProII Operators Manual 176 8 e r a C d n a e c n a n e t n a M 8 i anywhere on the test strip guide and cover at the completion of cleaning and disinfecting. Ensure that the test strip guide and cover are completely dry before assembling them. 7 WARNING! Reattach the test strip guide cover to the housing. Make sure that the cover is properly closed. You will hear it snap into place. CoaguChek ProII Operators Manual 8.5 Maintenance cleaning of the interior test strip guide in case of residue buildup 177 When to clean the test strip guide Over time, the Super SaniCloth Germicidal Disposable Wipes may leave a buildup of residue in the test strip guide. The test strip guide should be visually inspected and cleaned periodically as necessary or at least once per month. Approved cleaning agents Test strip guide: Use a cotton swab slightly dampened with water. NOTICE!
r Do not use any other cleaning solutions as this could result in damage to the system components. r To perform maintenance cleaning of the test strip guide 1 Open the cover. With the meter powered off, use your thumbnail to open the cover of the test strip guide by pressing its front edge upward. Move the cover safely away from the meter. Clean the inner side of the cover with a cotton swab and water. If necessary rinse the cover under tap water. 8 e r a C d n a e c n a n e t n a M 8 i CoaguChek ProII Operators Manual 178 8 e r a C d n a e c n a n e t n a M 8 i 2 Clean the interior test strip guide. Hold the meter upright with the test strip guide facing down. Clean the easily accessible area (shown in the magnified illustration: white area below cotton swab and its black surrounding frame) with a waterdampened cotton swab. Do not clean beyond the white area inside the meter. Ensure the swab is only damp, not wet. Wipe away residual moisture and fluids. Ensure the swab is only damp, not wet. Wipe away residual moisture and fluids. Carefully wipe the test strip guide dry using a dry cotton swab. Ensure that the test strip guide and cover are completely dry before assembling them. 3 NOTICE! Damage to the instrument Do not insert any objects into the test strip guide. Doing so could damage the electrical contacts behind the test strip guide. Close the cover and make sure it snaps into place. CoaguChek ProII Operators Manual 8.6 Cleaning the scanner window The scanner window should be cleaned periodically. Use a clean, dry cloth to wipe the scanner window. CoaguChek ProII Operators Manual 179 8 e r a C d n a e c n a n e t n a M 8 i 180 8.7 Cleaning after a notification appears appears on either the Main Menu or the If the icon QC Lockout screen, a cleaning/disinfection is necessary. A corresponding information message I-013 appears in the display, when entering the Main Menu or QC Lockout screen. Intervals between running cleaning process are determined by your facility. For further information on configuring these intervals refer to cobas IT 1000 Application CoaguChek Pro II Instrument Driver User Information. r Cleaning after a notification appears 1 If appears on the Main Menu screen, touch Cleaning. f Go to step 3. 2 Alternatively, if appears on the QC Lockout screen choose Control Test. Choosing the Control Test button initiates a control test run, since it has priority over cleaning. First run a liquid quality control test to unlock the meter from a QC Lockout before you can run a cleaning process. f Go to step 1. 8 e r a C d n a e c n a n e t n a M 8 i CoaguChek ProII Operators Manual Patient TestMain MenuCleaningReview ResultsSetup09:15 am05/29/2022Main MenuReview ResultsSetup09:15 am05/29/2022QC LockoutControl Test 3 The Power meter off and clean meter screen appears. Power off the meter and perform Cleaning and disinfecting the meter. f By powering off the meter, a device event is created that will be transferred to the DMS and the cleaning process is handled as done by the meter. 181 8 e r a C d n a e c n a n e t n a M 8 i CoaguChek ProII Operators Manual Cleaning09:15 am05/29/2022Power meter off and cleanmeter 182 Page intentionally left blank. CoaguChek ProII Operators Manual 9 Troubleshooting 9.1 Status / Error messages The CoaguChek ProII meter continually checks its systems for unexpected and unwanted conditions. These may arise for technical reasons (defective components or consumables, environmental factors) or due to handling and procedure errors. Depending on the circumstances, a message may appear on the display of the meter. These messages are marked with an icon, either for a status for an error message. All messages message, or displayed by the system are accompanied by a description of the error and a possible solution. Take the action suggested on screen to resolve the problem. If the error disappears, you may continue using the meter as desired. If the problem persists, contact Roche Diagnostics. The two different message types are illustrated below:
Message I-001: Battery Low Description Status message Touch to proceed with the next step. CoaguChek ProII Operators Manual 183 9 g n i t o o h s e b u o r T 9 l Battery LowThe battery is getting low.Attach external power supply orreturn meter to docking station. 184 9 g n i t o o h s e b u o r T 9 l Message Description E101: Patient ID Required Error message to exit this message. Perform the Touch suggested step(s) to solve the problem. Additional information on error E402 Message Description E-402 Test Strip Error Status message to exit this message. Perform the Touch suggested step(s) to solve the problem. Power the meter off and remove the test strip. Repeat the measurement using a new test strip and blood taken from a new puncture site at the tip of another finger. If this error message appears again when the test is repeated, contact your local Roche representative. Possible reasons for this error message to appear again and again:
The meter circuit board is defective. This can happen when, for example, cleaning and disinfecting agents enter the meter interior or when there are dried residues of cleaning and disinfecting agents in the meter interior. The test strip was wet or has already been used. CoaguChek ProII Operators Manual A patient ID is required. Enter avalid patient ID.Patient ID RequiredA test strip error was detected.Check your procedure and repeattest, using a new test strip ifnecessary.Test Strip Error Additional information on error E403 Message E-403: Dosing Error The sample was applied too early, before warming up of the strip was completed. Description Status message to exit this message. Perform the Touch suggested step(s) to solve the problem. Dosing refers to the procedure of applying the blood sample to the test strip. Dosing Error indicates that an insufficient sample volume was detected. Please check your procedure and repeat the test. Power the meter off and remove the test strip. Repeat the measurement using a new test strip and blood taken from a new puncture site at the tip of another finger. Make sure you apply a sufficient amount of blood to the test strip. If this error message appears again and again although the blood sample was sufficient, the meter might be contaminated with blood or residues of cleaning and disinfecting agents. If this error message persists when the test is repeated, contact your local Roche representative. CoaguChek ProII Operators Manual 185 9 g n i t o o h s e b u o r T 9 l A dosing error was detected.Check your procedure andrepeat test, using a new teststrip.Dosing Error 186 Additional information on error E406 Message Description E-406: Sample Error Status message to exit this message. Perform the Touch suggested step(s) to solve the problem. Power the meter off and remove the test strip. Repeat the measurement using a new test strip and blood taken from a new puncture site at the tip of another finger. Do not touch or remove the test strip when a test is in progress. Note on error E406: The CoaguChekPT Test strip may be used for patients under a combination therapy of oral anticoagulants plus heparin injections. For maximum heparin concentrations which do not interfere with the test, refer to the package insert. In rare cases, patients with abnormal or unusually long clotting times may receive an E406 message on the meter display. This may occur, for example, during treatment with vitamin K antagonists in combination with antibiotics, chemotherapeutics, or extremely high levels of vitamin C (e.g. after vitamin C infusions). If this error message appears again when the test is repeated, the result must be checked using another method. For further information on the measuring range of the parameter refer to the respective package insert. 9 g n i t o o h s e b u o r T 9 l CoaguChek ProII Operators Manual Sample ErrorUnsuitable sample composition.Check your procedure and repeattest with new strip and fresh sample.Check medication regimen of patient.If problem persists, check result withanother method and refer to manualfor more detail. Error History If capillary tubes are used, do not use glass capillary tubes or capillary tubes that contain anticoagulants. To check the error history of the CoaguChek ProII meter, you can scroll through the errors on the Error History screen via:
Main Menu > Setup > Diagnostics u 3.7 Diagnostics (108) Errors and unusual behavior without error messages Some conditions may arise that have no associated error or status message. If you notice any issues with the display functionality
(e.g. unexpected lines/marks on the meter display), stop using the system and contact your Roche representative. Message Description No message or unusual behavior Meter display does not power on Wait 10seconds and try powering on the meter again. Check that the meter has power See To install the battery pack (43) Is the battery pack properly installed in the meter?
Does the meter power on when connecting the external power adapter?
Does the battery pack charge properly?
CoaguChek ProII Operators Manual 187 9 g n i t o o h s e b u o r T 9 l 09:15 am05/29/202203/12/2022 08:00 am02/10/2022 08:30 am11/14/2021 07:30 am10/10/2021 07:05 am01/02/2022 10:17 amError History 188 9 g n i t o o h s e b u o r T 9 l Message Description Meter displays an unexpected result Refer to the package insert for the test strips. Automatic shutdown The meter powers off after a configurable time without activity (e.g., pressing a key, touching the screen) to conserve energy. Reactivate the meter/screen as described in the following:
Shutdown after time specified by system administrator (default is 5 minutes, configurable by system administrator) Press
. Additional information on result screens Message Description A C is displayed along with the result:
A * is displayed along with the result:
This may occur if the hematocrit value is very low or due to erroneous blood collection
(e.g., wet hands). Repeat the test. If using capillary blood, make sure that the patient's hands are dry. If the message persists, perform a hematocrit check. This may occur if the test result is out of normal range. Touch the the Out Of Normal Range information screen. icon to display When interpreting results, refer to the detailed information on limitations and interferences included in the limitations section of the test strip package insert. CoaguChek ProII Operators Manual 9.2 Shut down / restart / reset meter Shutting down the meter shuts down wireless communication and all other functionalities. Date and time, however, are maintained. r To shut down meter not connected to the external power supply or HBU 1 To shut down the meter, press the On/Off button for about 5seconds and release the button as soon as the Roche logo is displayed and the meter beeps. The screen goes blank and the meter is shut down. Use meter shutdown when you want to remove or replace the battery pack. See To remove the battery pack (45) r To shut down meter connected to the external power supply or HBU 1 To restart the meter, press the On/Off button for about 5seconds and release the button as soon as the Roche logo is displayed and the meter beeps. The screen goes blank and the meter powers itself off and on. Use meter restart if the meter does not respond to user actions (like touching buttons). Note: If you press the On/Off button for too long, a meter reset will be triggered after about 12seconds and date and time will be lost. See To reset the meter (190) CoaguChek ProII Operators Manual 189 9 g n i t o o h s e b u o r T 9 l 190 9 g n i t o o h s e b u o r T 9 l r Automatic shutdown If the battery pack is critically low, the meter will shut down automatically. r To reset the meter 1 A meter reset should only be performed if all other remedies have failed. 2 Place the meter on a level surface. 3 Press the ON/OFF button for at least 12seconds and then release it. After releasing the button, the meter will start up again. The meter powers off and on again. The Roche logo is displayed. If the Roche logo does not appear within 60seconds, place the meter in the Handheld Base Unit for a minimum of 15 minutes to recharge the battery. The meter performs a system check. The screens for entering the date and the time appear. 4 Enter the date and time. After you have entered the correct information, confirm each screen with
. Unless all lockouts are disabled, the meter will now be in QC Lockout due to the manually entered date/time. See 3.6 QC Settings setup (93) CoaguChek ProII Operators Manual Init 5 Synchronize the meters date/time with the date/
time of your facility via the Handheld Base Unit or, if working wirelessly, wait at least tenminutes for the next WLAN synchronization before performing any further tests. Even if your configuration does not require it, we recommend always performing a QC test after a meter reset. 191 9 g n i t o o h s e b u o r T 9 l CoaguChek ProII Operators Manual Date09:15 am05/29/2022Year:Month:Day:09:15 am05/29/2022TimeHour:Minute:AMPM 192 Page intentionally left blank. CoaguChek ProII Operators Manual 10 General Product Specifications 10.1 Technical data Technical data Operating temperature range
+12C to +32C (54F to 90F) 10 to 85% (no condensation) 4300m (14,000feet) Place the meter on a level, vibrationfree surface or hold it so it is roughly horizontal. Refer to respective test strip package insert 2000 patient and 500 QC results with date and time 120 code chip records (60 strip codes and 60 control codes) Operator lists up to 5000 Operator IDs with corresponding 2nd ID (e.g., Operator Name) Patient lists up to 4000 Patient IDs with corresponding 2nd and 3rd Patient IDs (e.g., name, date of birth) Touchscreen and barcode scanner Universal Battery Pack for the CoaguChek ProII meter Power supply adapter: Input: 100240VAC /
5060Hz / 400200mA (max.) Output: 12VDC / 1.25A (min.) approx. 60tests (PT/INR) at least 20tests (aPTT/measuring time: 5 minutes) III Programmable 1 60minutes 187 x 97 x 43mm 280g (without battery pack) Relative humidity Maximum altitude Position Measuring range Memory Interface Battery operation Power connection Number of tests with a fully charged battery pack Safety class Automatic poweroff Dimensions Weight CoaguChek ProII Operators Manual 193 0 1 s n o i t a c i f i c e p S t c u d o r P l a r e n e G 0 1 194 Sample material Sample type Sample size Interactions Storage conditions Refer to test strip package insert Refer to test strip package insert Refer to test strip package insert Temperature range Meter (without battery pack) 5C to +45C (+23F to +113F) Temperature range Meter (with battery pack) 5C to +35C (+23F to +95F) Relative humidity 10 to 85% (no condensation) Transport conditions Temperature range Meter
(without battery pack) 25C to +70C (13F to +158F) Temperature range Meter
(with battery pack contained in the kit)(a) 10C to +70C (+14F to +158F) Relative humidity 10 to 85% (no condensation)
(a) At temperatures above +70 C/158 F the battery pack could leak and damage the meter. At temperatures below 10C/+14F the battery pack does not have enough power to keep the internal clock functioning. 0 1 s n o i t a c i f i c e p S t c u d o r P l a r e n e G 0 1 CoaguChek ProII Operators Manual 10.2 Further information Consumables/
Accessories Below is a list of available accessories and consumables. For ordering information, contact your local sales representative (see Contact Roche). Item Description Remarks CoaguChekPT Test CoaguChekaPTT Test PT test strips for the CoaguChek ProII meter aPTT test strips for the CoaguChek ProII meter CoaguChekPT Controls CoaguChekaPTT Controls Optional liquid controls (Level1, Level2) for the CoaguChek ProII system International edition
(not available in the US) Universal Battery Pack Rechargeable battery pack Handheld Base Unit Handheld Base Unit and Operators Manual Reagents and solutions Supplies are available through Roche Diagnostics. Contact your local Roche Diagnostics representative. Product limitations Read the information in the package insert supplied with the reagents and solutions for detailed product data and limitations. Information about software licenses This product incorporates software modules developed under open source licenses. The source code of this software can be requested on a standard data exchange medium from the manufacturer at the following address:
Roche Diagnostics GmbH Sandhofer Str.116 68305 Mannheim, Germany CoaguChek ProII Operators Manual 195 0 1 s n o i t a c i f i c e p S t c u d o r P l a r e n e G 0 1 196 0 1 s n o i t a c i f i c e p S t c u d o r P l a r e n e G 0 1 Repairs Contact Roche The General Public License (GPL) licensing conditions are available (in English only for legal reasons) as a PDF file (file name License.txt.PDF) on the CD supplied with this manual. The complete license agreements are also stored as a text file (file name License.txt) on the Handheld Base Unit. You can access this file by connecting the Handheld Base Unit to a PC with the USB cable. For detailed instructions on how to do this, see the Operator's Manual of the Handheld Base Unit. Everyone is permitted to copy and distribute verbatim copies of this license document, but changing it is not allowed. Please note that repairs and other modifications to the meter may only be performed by persons authorized by Roche Diagnostics. For all questions about the CoaguChek ProII system that are not answered in this manual, contact your Roche Diagnostics representative. If you do not already have contact details, please visit our website at www.rochecanada.com or:
www.coaguchek.ca. In Canada, the CoaguChek Pro II system is distributed by:
Roche Diagnostics 201 Boul. ArmandFrappier Laval, Qubec (Canada) H7V 4A2 Telephone (region of Montral): (450) 6867050 Technical Support:
CoaguChek ProII Operators Manual Roche Care Center (toll free) 18772733433 www.rochecanada.com www.coaguchek.ca 197 0 1 s n o i t a c i f i c e p S t c u d o r P l a r e n e G 0 1 CoaguChek ProII Operators Manual 198 Page intentionally left blank. CoaguChek ProII Operators Manual 11 Warranty The statutory guarantee provisions on rights in consumer goods sales in the country of purchase shall apply. CoaguChek ProII Operators Manual 199 1 1 y t n a r r a W 1 1 200 Page intentionally left blank. CoaguChek ProII Operators Manual 12 Appendix A A.1 Operator and patient ID barcode masks Barcode mask character Definition AZ, 09 Dollar ($) Asterisk (*) Tilde (~) Plus (+) Caret (^) If not preceded by the Caret (^), the scan data character must be the same as the mask character. This character is not saved as part of the ID. If the characters are not the same, the scan data is not a valid ID. The scan data character in this position is kept as part of the ID. The scan data character in this position is not kept as part of the ID. The scan data character in this position must be a number, 09, and it is not kept as part of the ID. If the scan data character is not a number, the scan data is not a valid ID. The scan data character in this position must be an alpha character, A Z, and it is not kept as part of the ID. If the scan data character is not an alpha character, the scan data is not a valid ID. This mask character denotes that the scan data character must be equal to the next character in the barcode mask after the ^, and that the scan data character is kept as part of the ID. If the scan data character is not equal to the mask character following the ^, the barcode reading is invalid as an ID. The allowed maximum length of a barcode mask is 60characters for 1D barcodes 300characters for 2D barcodes CoaguChek ProII Operators Manual 201 i 2 1 A x d n e p p A 2 1 202 A.2 Example of barcode symbologies If a barcode is read incorrectly, this may lead to patient misidentification and therefore to inappropriate therapy decisions. r When creating patient or operator barcodes, always adhere to the applicable international IEC/ISO standards for the respective barcode symbology. In particular, ensure that barcode size and print quality (as defined in ISO/IEC15416 and 15415) are adequate. Inadequate print size and/or quality may lead to erroneous decoding. In addition every user must carry out a plausibility check on all data scanned into and displayed by the instrument. To reduce the probability of the barcode being misread, it is strongly recommended that you use the configuration options for patient and/or operator ID validation as applicable to your specific workflow. These options are:
check ID against list or check ID for length(12) use barcodes with check digits Always make sure that the entire barcode is covered by the green light beam when scanning. i 2 1 A x d n e p p A 2 1
(12) If no operator/patient list can be used, it is recommended that you at least set a minimum length for the respective ID, even if your facility uses IDs of varying length. CoaguChek ProII Operators Manual WARNING!
Avoidance of incorrect EAN13 and Interleaved 2/5 barcode readings EAN13 and Interleaved 2/5barcodes, although widely used, are not recommended for patient/operator barcodes. If an EAN13 or Interleaved 2/5barcode is read incorrectly, this may lead to patient misidentification and therefore to inappropriate therapy decisions. If used nonetheless:
r make sure that the very highest quality standards of barcode creation and reproduction are applied r for EAN13: do not use the start sequences 978
(ISBN) and 979 (ISMN) as they will be ignored as a part of any ID code. The barcode samples shown here are for illustration purposes only. If printed out, they can be used to check the barcode scanner. However, they are not meant to be used as a reference for size or resolution of real patient or operator ID barcodes. When creating patient or operator barcodes always refer to the relevant standard ISO/IEC15416 and 15415 for size and resolution requirements and to the specification listed below. Recommended Specification Remarks Print resolution 300dpi preferred 200dpi minimum Reflective contrast 70% or greater At 200dpi issues with the widetonarrow ratio may exist. Matte finish is preferred over gloss finish. CoaguChek ProII Operators Manual 203 i 2 1 A x d n e p p A 2 1 204 i 2 1 A x d n e p p A 2 1 Recommended Specification Remarks Symbol grade Grade C or above Grade B is preferred Module width (minimum) Symbol grades are AF based on analysis of several quality elements. 0.16mm (linear barcodes) 0.20mm (2D barcodes) Depending on quality grade parameters for a specific bar code, grade C may not be sufficient when motion, reflection, or poor lighting occur. Codabar Code93 EAN13 Interleaved2/5 with checksum Aztec Code39 Code128 Interleaved2/5 without checksum RSS (GS1DataBar Limited) DataMatrix CoaguChek ProII Operators Manual Roche DiagnosticsRoche Diagnostics PDF417 QR Code 205 i 2 1 A x d n e p p A 2 1 CoaguChek ProII Operators Manual Roche DiagnosticsRoche Diagnostics 206 A.3 Supported characters in 2D barcodes The 2Dbarcode scanner is able to read characters from the following unicode ranges:
Basic Latin (0021007E) Latin-1 Supplement (00A100FF) Latin Extended-A (0100017F) The 2Dbarcode scanner does not support Asian characters. i 2 1 A x d n e p p A 2 1 CoaguChek ProII Operators Manual 13 Appendix B B.1 Supplement for Observed Test Sequence Observed Test Sequence
(OTS) The Observed Test Sequence (OTS) function allows an observer (supervisor) to assess and record an operators performance (e.g., for recertification purposes). The observer monitors an operator during a test to check that the test is being performed according to the recommended procedures. He/she then evaluates the performance and passes or fails the operator. This assessment is saved together with the test result and any desired comments. Observed Test Sequence options can only be configured using a DMS. The availability of electronic configuration options will thus vary according to the data management software utilized by your institution. Consult your system administrator. CoaguChek ProII Operators Manual 207 i 3 1 B x d n e p p A 3 1 208 Using the OTS function A request for an Observed Test Sequence comes from the DMS. The presence of the icon on the Patient Test button indicates a pending OTS request. r To log on as an observer during OTS 1 Touch Patient Test. In the Pat. Test OTS menu, the Patient Test button is grayed out (disabled) until the observer has logged in. 2 Touch Observer Login. 3 Wait until the observer list is displayed. 4 Select your observerID by touching the corresponding button, or scan your operatorID
(which is also your observerID in this case). Only operators with OTS observer rights are listed in the Observer Login list. 5 Enter the (optional) password. 6 After you enter your password, touch to log in. The Pat. Test OTS menu is displayed again. The Patient Test button is now active. 7 Hand the meter to the operator who can now perform the patient test under supervision. i 3 1 B x d n e p p A 3 1 CoaguChek ProII Operators Manual 09:15 am05/29/2022Pat. Test - OTSOTS enabledObserver LoginPatient TestObserverAlan SmitheeAnn Casey09:15 am05/29/2022Scan09:15 am05/29/2022Pat. Test - OTSOTS enabledObserver LoginPatient TestMain Menu09:15 am05/29/2022Patient TestControl TestReview ResultsSetupLogout r To log on as an operator during OTS 1 Touch Patient Test. Perform the patient test as usual. Once the test is completed, the observer has to complete the next steps. 2 Hand the meter back to the observer. r To perform tasks as an observer during OTS 1 Touch to log in again. 2 After you enter your password, touch to proceed with the assessment. 3 Assess the operators performance by touching Pass or Fail. 4 Assess the test result by touching Accept or Reject. 5 Touch to add a comment. 6 Once you have selected the desired comment(s), to return to the Pat. Test - OTS screen, or to exit the Comment screen without adding touch touch a comment. 209 i 3 1 B x d n e p p A 3 1 CoaguChek ProII Operators Manual Pat. Test - OTS09:15 am05/29/2022OTS passed:Measurement Result OK?PassFailRejectAcceptComment:Observer LoginObserver %ls, please log in toproceed. Otherwise the OTStest will not be complete.Remove09:15 am05/29/202209:15 am05/29/2022Pat. Test - OTSOTS enabledObserver LoginPatient Test 210 i 3 1 B x d n e p p A 3 1 7 Touch to return to the Main Menu. The OTS information is saved together with the test result. CoaguChek ProII Operators Manual 14 Appendix C C.1 Option: Wireless network (WLAN) Preliminary note This appendix has been developed to explain the wireless communication principles of the CoaguChek ProII system(13) and to help your facilitys information technology/ management team(s) in effectively deploying the CoaguChek ProII system on your wireless network. Item Description REF/Catalog Number CoaguChek ProII meter Meter with WLAN functionality 07210841190 Background For information on WLAN registration see addendum WLAN registration information, Addendum to the Operator's Manual for the CoaguChek ProII meter at www.poc.roche.com (select the Products and Point of Care). The CoaguChek ProII meter can only be configured through a data management system to communicate wirelessly. The data management system (DMS) is also used to setup and configure the meter to connect to one hospital specific Wireless Local Area Network
(WLAN(14)). WLANs use electromagnetic waves in the 2.4GHz frequency range to wirelessly transmit data(15). The CoaguChek ProII system adheres to IEEE Standard 802.11g (2.4GHz range)(16). The system is backwards compatible to 802.11b. During wireless communication
(13) The CoaguChek ProII system is certified by the WiFi Alliance.
(14) WLAN is also commonly referred to as wireless LAN or WiFi.
(15) For the wireless functionality to work properly, the wireless module must first be configured by your system administrator.
(16) While the CoaguChek ProII system adheres to the 802.11g standard, it uses only channels 111. Channels 1214 are not used by the system. CoaguChek ProII Operators Manual 211 i 4 1 C x d n e p p A 4 1 212 i 4 1 C x d n e p p A 4 1 to an Access Point (AP), the CoaguChek ProII meter recognizes the existent AP WLAN protocol configuration (802.11b or 802.11g) and automatically transmits data using the appropriate communication protocol(17). The loss of signal or access to bandwidth of one particular client may vary depending on one or more of the following situations: the type and number of other clients, the performance of the Access Point, the presence of electromagnetic disturbances, and other potential interfering factors, e.g., concrete walls. The CoaguChek ProII meter uses a burstlike communication protocol that will only consume bandwidth if there is actually data to be transferred. Compared to other applications, such as Voice over Internet Protocol (VoIP) or multimedia applications, the meters bandwidth consumption is minimal. If the WLAN that the CoaguChek ProII meter seeks to connect to is degraded, the meter design minimizes the impact on functionality. Prior to connecting any wireless device to a wireless network, it is recommended that a WLAN site survey be performed. The goal of a WLAN site survey is to ensure that Access Points will provide enough coverage and performance to support any new radio frequency (RF) application or device. The survey will also detail RF signals, including all existing WLANs along with any competing RF signals and interferences (building structure related and other wireless equipment /
devices). Technical implementation
(17) WLANs are organized in cells. A typical WLAN cell consists of Access Point(s) that are connected to the
(wired) Local Area Network and one or more clients, e.g., CoaguChek ProII meters along with other clients such as portable computers. CoaguChek ProII Operators Manual As part of an RF implementation of the CoaguChek ProII system, it is recommended that at minimum one Handheld Base Unit be hard wired per floor. A networked Handheld Base Unit provides redundancy if a wireless network malfunctions or loses service. If the CoaguChek ProII meter with RF is used in an area with low signal or interferences, it is recommended to install a connected Handheld Base Unit for redundancy. The redundancy of the connected Handheld Base Unit allows immediate transmission of patient results when the meter is docked. The current RF system consists of an antenna and a WLAN systemonchip (SoC) along with other components. The WLAN systemonchip is the core of the WLAN system. The RF system used in the CoaguChek ProII meter specifically adheres to the following specifications:
Its WLAN systemonchip supports IEEE 802.11b and 802.11g. It works seamlessly together with other WiFi certified transceivers. It also implements the WiFi Protected Access (WPA - Enterprise and WPA - Personal), WiFi Protected Access 2 (WPA2
- Enterprise and WPA2 - Personal), and Wired Equivalent Privacy (WEP) security mechanisms with Temporal Key Integrity Protocol (TKIP) and Advanced Encryption Standard (AES). In addition, the system supports the extensible authentication protocol (EAP) with EAPTLS, EAPTTLS/ MSCHAPv2 and PEAPv0/EAPMSCHAPv2. The CoaguChek ProII meter interoperability WiFi certificate can be accessed at http://certifications.wifi.org/
search_products.php. Further information including a glossary of terms, frequently asked questions, and other topics related to WiFi technology can be found on the WiFi Alliance site (http://
www.wifi.org/). 213 i 4 1 C x d n e p p A 4 1 CoaguChek ProII Operators Manual RF specific functionalities and effective performance claims 214 i 4 1 C x d n e p p A 4 1 The used channels in the 2.4GHzband are channels 111, which are the legally allowed channels in the USA. (Channels 1214 are not used by the CoaguChek ProII meter.) RF output power is approximately 15dBm at a data rate of 54MBPS. The CoaguChek ProII system offers the option of wireless network connectivity (WLAN/WiFi). This module can only be configured by a data management system (DMS), which activates the meters wireless communication and data transfer capabilities. Wireless connectivity can help to ensure that updates to information in the DMS are sent immediately to all networked meters. Meters with an integrated and activated wireless option use the Handheld Base Unit for recharging and/or as a redundant communication option to exchange data with the DMS. The meter also has to be docked if the hospital changes security protocols. When this change occurs, it may lock out all meters until docked and reconfigured with the new protocol. As described above, the CoaguChek ProII meter supports the 802.11g standard. This translates into the following RF specific performance claims:
The CoaguChek ProII meter is capable of transferring to a suitable DMS, via WLAN, a data set of up to 1000 result records, 100 strip and control lot records, and 500 operator ID records in less than 15 minutes, when operated in a typical WLAN environment (correct WLAN administration, typical population of other clients present, any of the supported security models enabled). CoaguChek ProII Operators Manual 215 Immediately after the test has been completed (and returning to the main menu screen), the CoaguChek ProII meter will attempt to connect to the DMS. In line with the industry communication standard POCT1A, the DMS must acknowledge the meters request for connection and actively query for the result. Only upon receipt of this DMS query, the meter will send the result. Hence the effective time for transmitting results depends on infrastructure, DMS workload, etc. Once the DMS sends a query, however, the meter will respond within a few seconds. A CoaguChek ProII meter with wireless connectivity enabled, communicates results after every test. When the meter is idle while docked, it automatically attempts to communicate with the DMS every 30 minutes. Whenever the meter is placed in the HBU or connected to the power adapter for recharging, it will automatically attempt to communicate with the DMS if the battery is still sufficiently charged. A typical range for direct connection between the CoaguChek ProII meter and the access point (air, direct view, low disturbances) is up to 15 to 20meters (49 to 66feet). The actual range depends on the positioning of the access points antennas and other topological properties of the space between WLAN device and AP. Additionally, dynamic control of the transmitting power of the access point may reduce the maximum distance between WLAN device and AP within which communication can be guaranteed. The CoaguChek ProII system is designed such that it coexists with other wirelessly communicating devices. The CoaguChek ProII system does NOT include any real-time or even time critical wireless functionality. It communicates exclusively single, digital data fields. It does NOT communicate continuous waveform data. i 4 1 C x d n e p p A 4 1 CoaguChek ProII Operators Manual 216 i 4 1 C x d n e p p A 4 1 Note: A degraded WLAN connectivity will not impact the functionality of the meter but may delay the communication of results to the DMS. Users should be aware that realtime communication of data cannot be guaranteed by the CoaguChek ProII meter. During the exchange of large data packages a shortterm delay in the meter response might occur. CoaguChek ProII Operators Manual 217 Index A Accessories..................................195 Adapter (power supply) .....................39 Admin. ID ..................................86, 88 Applying a blood sample..................124 Auto Off ........................................71 B Barcode......................... 120, 122, 139 Masks........................................201 Symbologies ........................ 202, 204 Barcode scanner .............................32 Battery pack Installing or replacing .......... 42, 43, 45 Beeper ..................... 69, 138, 147, 148 Blood sample (testing) ............. 115, 120 C Capillary blood sample (testing) 115, 120, 124 Cleaning ...........167, 170, 173, 177, 179 Interior test strip guide..................177 Meter housing .............................170 Test strip guide .................... 173, 177 Connection..................... 72, 73, 75, 77 Consumables ................................195 Contrast ........................................58 Control solution Applying ....................................141 Code chip ..................................139 Preparing ...................................134 Custom range ............................94, 95 D Data transfer ......................... 157, 158 Database Configure.....................................78 Date .............................................64 Disinfection .......167, 170, 173, 177, 179 Display .....................................35, 36 Format ........................................66 Icons...........................................34 Disposal........ 22, 40, 114, 129, 142, 149 E Encryption TLS........................................75, 77 Error messages .............................183 Coagulation process.......................124 Code chip ....................................115 F Inserting ....................................116 Fingertip ......................................124 Code number ................................116 Comments Adding ......................................128 Computer.......................................75 CoaguChek ProII Operators Manual 218 H Handheld Base Unit ... 32, 42, 47, 75, 157, 195, 212 I Icons........................................35, 36 Drop .........................................124 Dropper.............................. 140, 148 Hourglass .................... 124, 140, 148 Identification plate .......................... 6 Overview......................................34 Packaging ..................................... 6 ID Setup Overview......................................84 Infrared interface.............................32 K Keypad ........................................122 L Lance..........................................124 Language.......................................62 Lockout Measurement Performing ............ 120, 124, 129, 130 Preparing ...................................115 Measuring range ............................193 Memory Button.......................................152 Patient Result .............................153 Quality Control............................155 Meter Overview......................................32 Reset ........................................190 O Observed Test Sequence (OTS) .. 207, 208 Operating conditions .................30, 193 Operator Lockout .............................. 100, 103 Logout ......................................119 Password ...................................119 Operator ID ....................................89 Operator list .......................... 118, 158 Options .......... 68, 69, 71, 72, 73, 75, 77 Overview........................................53 Meter elements .............................32 Setup ..........................................51 Operator ............................ 100, 103 Quality Control.......................98, 120 P Logout ........................................119 M Mains voltage...........................30, 193 Maintence cleaning Interior test strip guide..................177 Test strip guide ...........................177 CoaguChek ProII Operators Manual Parameter selection ..................82, 152 Password .....................................119 Patient ID .......................................90 Patient list............................. 122, 159 Power adapter ................................39 Power on......................................117 219 Power supply Charging contacts, (Handheld Base Unit)
.................................................32 S Safety Printer...........................................77 Incident reporting ..........................19 Product specifications ....................193 Protection against infection .............20 Proficiency sample User qualification...........................19 Applying ....................................148 Scan (button) ......................... 122, 139 Proficiency test Scan configuration ...........................81 Preparing ...................................145 Screen ...... 58, 59, 60, 61, 62, 64, 65, 66 Putting the meter into operation41, 42, 47 Setup Q QC Range ......................................94 QC Settings ......................... 93, 94, 98 QR code ........................................73 Quality Control Lockout ................................98, 120 Memory .....................................155 Preparing ...................................134 Result ......................... 141, 142, 149 R Relative humidity ......................30, 193 Remote service................................80 Reset ..........................................190 Result confirmation ...................61, 127 Review Results ..151, 152, 153, 155, 157, 158, 159, 161, 162 Data transfer ....................... 157, 158 RF (radio frequency) ..................27, 212 CoaguChek ProII Operators Manual Admin. ID ................................86, 88 Auto Off ......................................71 Beeper ........................................69 Computer ....................................75 Connection .................. 72, 73, 75, 77 Contrast ......................................58 Date ...........................................64 Display format...............................66 ID Setup.................. 84, 86, 88, 89, 90 Language.....................................62 Operator ID ..................................89 Options ........ 68, 69, 71, 72, 73, 75, 77 Parameter selection .......................82 Patient ID .....................................90 Printer.........................................77 QR code ......................................73 Remote service .............................80 Result confirmation ........................61 Scan configuration .........................81 Screen .... 58, 59, 60, 61, 62, 64, 65, 66 Sort ............................................68 STAT test ...................................104 Time ...........................................65 Units ......................................59, 60 Software license ............................195 Sort ..............................................68 W Warranty......................................199 WiFi .............................................28 WLAN............................ 211, 212, 214 220 STAT test Configure...................................104 Perform .....................................130 Storage .......................................165 Switching on the meter....................117 Symbols Error messages ...........................183 System Administrator...................86, 88 T Target value ...................................97 Temperature range ...................30, 193 Test principle ..................................16 Test result (patient test) ..................126 Test result (quality control) 141, 142, 149 Test strip Icon ................................... 123, 147 Inserting ...................... 138, 147, 148 Test strip guide cover .............. 173, 177 Thromboplastin ...............................16 Time .............................................65 TLS Encryption ..............................75, 77 Troubleshooting ............................183 U Unit (test result).............................126 Units (of measure) .......................59, 60 V Voltage .........................................30 CoaguChek ProII Operators Manual Page intentionally left blank. ACCUCHEK, COAGUCHEK and SAFETPRO are trademarks of Roche. Distributed in Canada by:
Roche Diagnostics 201 Boul. ArmandFrappier Laval, Qubec (Canada) H7V 4A2 Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.rochecanada.com www.coaguchek.ca N A C
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1 2 | Label | ID Label/Location Info | 24.83 KiB | July 14 2023 |
CoaguChek Pro II (2) Model Rev.: CC Pro Il 4.5 FCC ID: VO9-CCPROI IC ID: 3100B-CCPROII TA-20 XXX
(CMIIT ID: XXXXXXXXXX ANATEL: XXX IFETEL: XXX EC XXavYyyyZzzw MSIP-CRM- XXX CNC ID: Xxx LJ
& 09578331001(01)
1 2 | 2.911(d)(5) letter | Attestation Statements | 467.58 KiB | July 14 2023 |
Roche Diagnostics GmbH Sandhofer StraBe 116 D-68305 Mannheim Federal Communication Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA 2023-April-27 Attestation Statement according to 2.911(d)(5)(i) and 2.911(d)(5)(ii) FCC ID: VO9-CCPROII TO WHOM IT MAY CONCERN:
Hereby we certify that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Further we certify that, as of the date of the filing of the application, Roche Diagnostics GmbH is not identified on the Covered List as an entity producing covered equipment. Sincerely, GALE
(signature & company stamp) Roche Diagnostics GmbH Sandhofer StraBe 116; D-68305 Mannheim Ralf Schmitz
+49 621 7594104 ralf.schmitz@roche.com 1/1 Roche Diagnostics GmbH Sandhofer StraBe 116; D-68305 Mannheim; Telefon +49-621-759-0; Telefax +49-621-759-2890 Sitz der Gesellschaft: Mannheim - Registergericht: AG Mannheim HRB 3962 - Geschaftsftihrung: Dr. Claudia Fleischer; Clemens Schmid -
Aufsichtsratsvorsitzender: Dr. Thomas Schinecker Confidentiality Note This message is intended only for the use of the named recipient(s) and may contain confidential and/or privileged information. If you are not the intended recipient, please contact the sender and delete the message. Any unauthorized use of the information contained in this message is prohibited.
1 2 | 2.911(d)(7) letter | Attestation Statements | 281.13 KiB | July 14 2023 |
Roche Diagnostics GmbH Sandhofer Strafe 116 D-68305 Mannheim Federal Communication Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Attestation Statement according to 2.911(d)(7) TO WHOM IT MAY CONCERN:
We, Roche Diagnostics GmbH with FCC Registration Number (FRN) 0016954943 designate C T Corporation System to act as U.S. agent for service of process. CT Corporation System (C T Corporation System does not do any business with FCC and therefore has nor own FRN) hereby acknowledges the obligation of the U.S. agent for service of process. Further Roche Diagnostics GmbH accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Roche Diagnostics GmbH Sandhofer StraRe 116 68305 Mannheim Sincerely
(signature & company stamp) Roche Diagnostics GmbH C T Corporation System Sandhofer Strafe 116; D-68305 Mannheim 1015 15* Street N.W., Suite 1000, Washington, Ralf Schmitz D.C., 20005
+49 621 7594104 Stephanie Hencz ralf.schmitz@roche.com 202-572-3133 CTSOPReceipt@wolterskluwer.vom R oche Diagnostics GmbH Sandhofer StraBe 116; D-68305 Mannheim; Telefon +49-621-759-0; Telefax +49-621-759-2890 Sitz der Gesellschaft: Mannheim - Registergericht: AG Mannheim HRB 3962 - Geschaftsfihrung: Dr. Claudia Fleischer; Clemens Schmid -
Aufsichtsratsvorsitzender: Dr. Thomas Schinecker Confidentiality Note This message is intended only for the use of the named recipient(s) and may contain confidential and/or privileged information. If you are not the intended recipient, please contact the sender and delete the message. Any unauthorized use of the information contained in this message is prohibited.
1 2 | LTC | Cover Letter(s) | 226.68 KiB | July 14 2023 |
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5
ee i a ee ade LONG-TERM CONFIDENTIALITY REQUEST for Certification Service in the USA Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 TO WHOM IT MAY CONCERN Pursuant to Paragraphs 0.457 and 0.459 of the Commissions Rules (47 C.F.R.) and Section 552(b)(4) of the Freedom of Information Act, we request Long-Term Confidentiality for the following product:
For the product stated above, we request Long-Term Confidentiality for exhibits which contain Block Diagram, Operational Description, Parts List/Tune Up Info, Schematics, SDR Software/Security Info. The above exhibits contain our trade secrets and proprietary information that could be of benefit to our competitors. This information will not be publicly available. If you have any questions, please feel free to contact us at the address shown below. Sincerely, Roche Diagnostics GmbH +49-621-759-0 Sandhofer StraBe 116 +49-621-759-2890 Company |
Address: Mannheim Ralf.Schmitz@Roche.com Contact Name:
; Signature Signature:
Date:
Roche Diagnostics GmbH Sandhofer StraBe 116; D-68305 Mannheim: Telefon +49-621-759-0; Telefax +49-62 1-759-2890 Sitz der Gesellschaft: Mannheim - Registergericht: AG Mannheim HRB 3962 - Geschaftsftihrung: Dr. Claudia Fleischer; Clemens Schmid -
Aufsichtsratsvorsitzender: Dr. Thomas Schinecker Confidentiality Note This message is intended only for the use of the named recipient(s) and may contain confidential and/or privileged information. If you are not the intended recipient, please contact the sender and delete the message. Any unauthorized use of the information contained in this message is prohibited.
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2023-07-14 | 5745 ~ 5825 | NII - Unlicensed National Information Infrastructure TX | Original Equipment |
2 | 2412 ~ 2462 | DTS - Digital Transmission System |
app s | Applicant Information | |||||
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1 2 | Effective |
2023-07-14
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1 2 | Applicant's complete, legal business name |
Roche Diagnostics GmbH
|
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1 2 | FCC Registration Number (FRN) |
0016954943
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1 2 | Physical Address |
Sandhofer Strasse 116
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1 2 |
Mannheim, N/A
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1 2 |
Germany
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app s | TCB Information | |||||
1 2 | TCB Application Email Address |
t******@ctcadvanced.com
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1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
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app s | FCC ID | |||||
1 2 | Grantee Code |
VO9
|
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1 2 | Equipment Product Code |
CCPROII
|
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
C**** P******
|
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1 2 | Telephone Number |
+4962******** Extension:
|
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1 2 | Fax Number |
+4962********
|
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1 2 |
c******@roche.com
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app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | NII - Unlicensed National Information Infrastructure TX | ||||
1 2 | DTS - Digital Transmission System | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | blood measuring instrument | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | Output power listed is average conducted. This device supports IEEE 802.11a (Wi-Fi 2) with a 20 MHz bandwidth mode and IEEE 802.11n (Wi-Fi 4) with a 20 MHz, 40 MHz bandwidth mode. For body worn and extremities operation this device has been tested touched to the phantom and meets FCC RF exposure guidelines. The highest reported SAR for body-worn and extremities SAR exposure conditions are 0.13 W/kg and 0.04 W/kg, respectively. | ||||
1 2 | Output power listed is peak conducted. This device supports IEEE 802.11b (Wi-Fi 1) with a 20 MHz bandwidth mode, IEEE 802.11g (Wi-Fi 3) with a 20 MHz bandwidth mode and IEEE 802.11n (Wi-Fi 5) with a 20 MHz, 40 MHz bandwidth mode. For body worn and extremities operation this device has been tested touched to the phantom and meets FCC RF exposure guidelines. The highest reported SAR for body-worn and extremities SAR exposure conditions are 0.06 W/kg and 0.03 W/kg, respectively. | |||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
CTC advanced GmbH
|
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1 2 | Name |
G******** S********
|
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1 2 | Telephone Number |
49-68********
|
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1 2 | Fax Number |
49-68********
|
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1 2 |
m******@ctcadvanced.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15E | CC | 5180 | 5240 | 0.01905 | |||||||||||||||||||||||||||||||||||
1 | 2 | 15E | CC | 5745 | 5825 | 0.00562 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 2412.00000000 | 2462.00000000 | 0.1905500 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC